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COVID-19 shifts telehealth to the center of cardiology
during the COVID-19 pandemic.
During a recent telehealth webinar, Ami Bhatt, MD, director of the adult congenital heart disease program, Massachusetts General Hospital, Boston, said they’ve gone from seeing 400 patients a day in their clinic to fewer than 40 and are trying to push that number even lower and use virtual care as much as possible.
“The reason is we are having to send home physicians who are exposed and it’s cutting into our workforce very quickly. So the more people you could have at home doing work virtually is important because you’re going to need to call them in [during] the next couple of weeks,” she said. “And our PPE [personal protective equipment] is running low. So if we can afford to not have someone come in the office and not wear a mask because they had a cough, that’s a mask that can be used by someone performing CPR in an ICU.”
The hospital also adopted a train-the-trainer method to bring its existing telehealth program to cardiology, said Dr. Bhatt, who coauthored the American College of Cardiology’s recent guidance on establishing telehealth in the cardiology clinic.
“We find that sending people tip sheets and PowerPoints in addition to everything that is happening ... is too much,” Dr. Bhatt observed. “So actually holding your friend’s hand and walking them through it once you’ve learned how to do it has been really great in terms of adoption. Otherwise, everyone would fall back on phone, which is OK for now, but we need to establish a long-term plan.”
During the same March 20 webinar, David Konur, CEO of the Cardiovascular Institute of the South, Houma, La., said they began doing telecardiology more than 5 years ago and now do about 30,000 “patient touches” a month with 24/7 access.
“This is certainly an unprecedented time,” he said. “COVID-19 is shining a very bright light on the barriers that exist in health care, as well as the friction that exists to accessing care for all of our patients.”
New mandates
A new Food and Drug Administration policy, temporarily relaxing prior guidance on certain connected remote monitoring devices such as ECGs and cardiac monitors, is part of a shifting landscape to reduce barriers to telehealth during the ongoing pandemic. The increased flexibility may increase access to important patient physiological data, while eliminating unnecessary patient contact and easing the burden on healthcare facilities and providers, the agency said in the new guidance, issued March 20.
As such, the FDA “does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared noninvasive remote monitoring devices that are used to support patient monitoring.”
Modifications could include the addition of monitoring statements for patients with COVID-19 or coexisting conditions such as hypertension and heart failure; a change to the indications or claims related to home use of devices previously cleared for use only in health care settings; and changes to hardware or software to increase remote monitoring capability. The approved devices listed in the guidance are clinical electronic thermometers, ECGs, cardiac monitors, ECG software for over-the-counter use, pulse oximetry, noninvasive blood pressure monitors, respiratory rate/breathing frequency monitors, and electronic stethoscopes.
The FDA policy comes just days after the Centers for Medicare & Medicaid Services expanded telehealth coverage to Medicare beneficiaries and the Office for Civil Rights at the U.S. Department of Health & Human Services said it would not penalize health care providers for using such non–HIPAA compliant third-party apps as Skype or Google Hangouts video. The HHS also signaled that physicians would be allowed to practice across state lines during the COVID-19 crisis.
“All these mandates have come in a time of desperation where we’re doing the best that we can to provide for patients and keep them safe,” Eugenia Gianos, MD, system director of cardiovascular prevention at Northwell Health and director of the Women’s Cardiovascular Center, Lenox Hill Hospital, New York, said in an interview. “Realistically, the whole digital realm has a lot of promise for our patients.” She noted that telehealth programs are still being developed for the department, but that office visits have been purposely scaled back by more than 75% to protect patients as well as health care providers. “In times of need, the most promising technologies we have, have to come to the forefront,” Dr. Gianos said. “So using the data from the home – whether they have a blood pressure cuff or something that tracks their heart rate or their weight – when we don’t otherwise have data, is of great value.”
Andrew M. Freeman, MD, director of clinical cardiology and operations at National Jewish Hospital in Denver, said “in the current situation, telehealth is the most viable option because it keeps patients safe and physicians safe. So it wouldn’t surprise me if every institution in the country, if not worldwide, is very rapidly pursuing this kind of approach.”
Exactly how many programs or cardiologists were already using telehealth is impossible to say, although the ACC is planning to survey its members on their practices during the COVID-19 pandemic, he noted.
The situation is so fluid that ACC is already revising its March 13 telehealth guidance to reflect the recent policy changes. Another document is being prepared to provide physicians with a template for the telehealth space, said Dr. Freeman, who coauthored the telehealth guidance and also serves on the ACC’s Innovation Leadership Council.
The new FDA policy allowing greater flexibility on remote monitoring devices is somewhat “vaguely worded,” Dr. Freeman noted, but highlights the ability of existing technology to provide essential patient data from home. “I think as we add adjuncts to the things we’re used to in the normal face-to-face visit, it’s going to make the face-to-face visit less required,” he said.
Questions remain, however, on implementing telehealth for new patients and whether payers will follow HHS’s decision not to conduct audits to ensure a prior relationship existed. The potential for telehealth to reach across state lines also is being viewed cautiously until tested legally, Dr. Freeman observed.
“If there’s one blessing in this awful disease that we have received, is that it may really give the power to clinicians, hospital systems, and payers to make telehealth a true viable, sustainable solution for good care that’s readily available to folks,” he said.
Fast-tracked research
On March 24, the American Heart Association announced it is committing $2.5 million for fast-tracked research grants for projects than can turn around results within 9-12 months and focus on how this novel coronavirus affects heart and brain health.
Additional funding also will be made available to the AHA’s new Center for Health Technology & Innovation’s Strategically Focused Research Networks to develop rapid technology solutions to aid in dealing with the pandemic.
The rapid response grant is an “unprecedented but logical move for the organization in these extraordinary times,” AHA President Bob Harrington, MD, chair of medicine at Stanford (Calif.) University, said in a statement. “We are committed to quickly bringing together and supporting some of the brightest minds in research science and clinical care who are shovel ready with the laboratories, tools, and data resources to immediately begin work on addressing this emergent issue.”
Dr. Freeman and Dr. Bhatt have disclosed no relevant financial relationships. Dr. Harrington is on the editorial board for Medscape Cardiology.
A version of this article originally appeared on Medscape.com
during the COVID-19 pandemic.
During a recent telehealth webinar, Ami Bhatt, MD, director of the adult congenital heart disease program, Massachusetts General Hospital, Boston, said they’ve gone from seeing 400 patients a day in their clinic to fewer than 40 and are trying to push that number even lower and use virtual care as much as possible.
“The reason is we are having to send home physicians who are exposed and it’s cutting into our workforce very quickly. So the more people you could have at home doing work virtually is important because you’re going to need to call them in [during] the next couple of weeks,” she said. “And our PPE [personal protective equipment] is running low. So if we can afford to not have someone come in the office and not wear a mask because they had a cough, that’s a mask that can be used by someone performing CPR in an ICU.”
The hospital also adopted a train-the-trainer method to bring its existing telehealth program to cardiology, said Dr. Bhatt, who coauthored the American College of Cardiology’s recent guidance on establishing telehealth in the cardiology clinic.
“We find that sending people tip sheets and PowerPoints in addition to everything that is happening ... is too much,” Dr. Bhatt observed. “So actually holding your friend’s hand and walking them through it once you’ve learned how to do it has been really great in terms of adoption. Otherwise, everyone would fall back on phone, which is OK for now, but we need to establish a long-term plan.”
During the same March 20 webinar, David Konur, CEO of the Cardiovascular Institute of the South, Houma, La., said they began doing telecardiology more than 5 years ago and now do about 30,000 “patient touches” a month with 24/7 access.
“This is certainly an unprecedented time,” he said. “COVID-19 is shining a very bright light on the barriers that exist in health care, as well as the friction that exists to accessing care for all of our patients.”
New mandates
A new Food and Drug Administration policy, temporarily relaxing prior guidance on certain connected remote monitoring devices such as ECGs and cardiac monitors, is part of a shifting landscape to reduce barriers to telehealth during the ongoing pandemic. The increased flexibility may increase access to important patient physiological data, while eliminating unnecessary patient contact and easing the burden on healthcare facilities and providers, the agency said in the new guidance, issued March 20.
As such, the FDA “does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared noninvasive remote monitoring devices that are used to support patient monitoring.”
Modifications could include the addition of monitoring statements for patients with COVID-19 or coexisting conditions such as hypertension and heart failure; a change to the indications or claims related to home use of devices previously cleared for use only in health care settings; and changes to hardware or software to increase remote monitoring capability. The approved devices listed in the guidance are clinical electronic thermometers, ECGs, cardiac monitors, ECG software for over-the-counter use, pulse oximetry, noninvasive blood pressure monitors, respiratory rate/breathing frequency monitors, and electronic stethoscopes.
The FDA policy comes just days after the Centers for Medicare & Medicaid Services expanded telehealth coverage to Medicare beneficiaries and the Office for Civil Rights at the U.S. Department of Health & Human Services said it would not penalize health care providers for using such non–HIPAA compliant third-party apps as Skype or Google Hangouts video. The HHS also signaled that physicians would be allowed to practice across state lines during the COVID-19 crisis.
“All these mandates have come in a time of desperation where we’re doing the best that we can to provide for patients and keep them safe,” Eugenia Gianos, MD, system director of cardiovascular prevention at Northwell Health and director of the Women’s Cardiovascular Center, Lenox Hill Hospital, New York, said in an interview. “Realistically, the whole digital realm has a lot of promise for our patients.” She noted that telehealth programs are still being developed for the department, but that office visits have been purposely scaled back by more than 75% to protect patients as well as health care providers. “In times of need, the most promising technologies we have, have to come to the forefront,” Dr. Gianos said. “So using the data from the home – whether they have a blood pressure cuff or something that tracks their heart rate or their weight – when we don’t otherwise have data, is of great value.”
Andrew M. Freeman, MD, director of clinical cardiology and operations at National Jewish Hospital in Denver, said “in the current situation, telehealth is the most viable option because it keeps patients safe and physicians safe. So it wouldn’t surprise me if every institution in the country, if not worldwide, is very rapidly pursuing this kind of approach.”
Exactly how many programs or cardiologists were already using telehealth is impossible to say, although the ACC is planning to survey its members on their practices during the COVID-19 pandemic, he noted.
The situation is so fluid that ACC is already revising its March 13 telehealth guidance to reflect the recent policy changes. Another document is being prepared to provide physicians with a template for the telehealth space, said Dr. Freeman, who coauthored the telehealth guidance and also serves on the ACC’s Innovation Leadership Council.
The new FDA policy allowing greater flexibility on remote monitoring devices is somewhat “vaguely worded,” Dr. Freeman noted, but highlights the ability of existing technology to provide essential patient data from home. “I think as we add adjuncts to the things we’re used to in the normal face-to-face visit, it’s going to make the face-to-face visit less required,” he said.
Questions remain, however, on implementing telehealth for new patients and whether payers will follow HHS’s decision not to conduct audits to ensure a prior relationship existed. The potential for telehealth to reach across state lines also is being viewed cautiously until tested legally, Dr. Freeman observed.
“If there’s one blessing in this awful disease that we have received, is that it may really give the power to clinicians, hospital systems, and payers to make telehealth a true viable, sustainable solution for good care that’s readily available to folks,” he said.
Fast-tracked research
On March 24, the American Heart Association announced it is committing $2.5 million for fast-tracked research grants for projects than can turn around results within 9-12 months and focus on how this novel coronavirus affects heart and brain health.
Additional funding also will be made available to the AHA’s new Center for Health Technology & Innovation’s Strategically Focused Research Networks to develop rapid technology solutions to aid in dealing with the pandemic.
The rapid response grant is an “unprecedented but logical move for the organization in these extraordinary times,” AHA President Bob Harrington, MD, chair of medicine at Stanford (Calif.) University, said in a statement. “We are committed to quickly bringing together and supporting some of the brightest minds in research science and clinical care who are shovel ready with the laboratories, tools, and data resources to immediately begin work on addressing this emergent issue.”
Dr. Freeman and Dr. Bhatt have disclosed no relevant financial relationships. Dr. Harrington is on the editorial board for Medscape Cardiology.
A version of this article originally appeared on Medscape.com
during the COVID-19 pandemic.
During a recent telehealth webinar, Ami Bhatt, MD, director of the adult congenital heart disease program, Massachusetts General Hospital, Boston, said they’ve gone from seeing 400 patients a day in their clinic to fewer than 40 and are trying to push that number even lower and use virtual care as much as possible.
“The reason is we are having to send home physicians who are exposed and it’s cutting into our workforce very quickly. So the more people you could have at home doing work virtually is important because you’re going to need to call them in [during] the next couple of weeks,” she said. “And our PPE [personal protective equipment] is running low. So if we can afford to not have someone come in the office and not wear a mask because they had a cough, that’s a mask that can be used by someone performing CPR in an ICU.”
The hospital also adopted a train-the-trainer method to bring its existing telehealth program to cardiology, said Dr. Bhatt, who coauthored the American College of Cardiology’s recent guidance on establishing telehealth in the cardiology clinic.
“We find that sending people tip sheets and PowerPoints in addition to everything that is happening ... is too much,” Dr. Bhatt observed. “So actually holding your friend’s hand and walking them through it once you’ve learned how to do it has been really great in terms of adoption. Otherwise, everyone would fall back on phone, which is OK for now, but we need to establish a long-term plan.”
During the same March 20 webinar, David Konur, CEO of the Cardiovascular Institute of the South, Houma, La., said they began doing telecardiology more than 5 years ago and now do about 30,000 “patient touches” a month with 24/7 access.
“This is certainly an unprecedented time,” he said. “COVID-19 is shining a very bright light on the barriers that exist in health care, as well as the friction that exists to accessing care for all of our patients.”
New mandates
A new Food and Drug Administration policy, temporarily relaxing prior guidance on certain connected remote monitoring devices such as ECGs and cardiac monitors, is part of a shifting landscape to reduce barriers to telehealth during the ongoing pandemic. The increased flexibility may increase access to important patient physiological data, while eliminating unnecessary patient contact and easing the burden on healthcare facilities and providers, the agency said in the new guidance, issued March 20.
As such, the FDA “does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared noninvasive remote monitoring devices that are used to support patient monitoring.”
Modifications could include the addition of monitoring statements for patients with COVID-19 or coexisting conditions such as hypertension and heart failure; a change to the indications or claims related to home use of devices previously cleared for use only in health care settings; and changes to hardware or software to increase remote monitoring capability. The approved devices listed in the guidance are clinical electronic thermometers, ECGs, cardiac monitors, ECG software for over-the-counter use, pulse oximetry, noninvasive blood pressure monitors, respiratory rate/breathing frequency monitors, and electronic stethoscopes.
The FDA policy comes just days after the Centers for Medicare & Medicaid Services expanded telehealth coverage to Medicare beneficiaries and the Office for Civil Rights at the U.S. Department of Health & Human Services said it would not penalize health care providers for using such non–HIPAA compliant third-party apps as Skype or Google Hangouts video. The HHS also signaled that physicians would be allowed to practice across state lines during the COVID-19 crisis.
“All these mandates have come in a time of desperation where we’re doing the best that we can to provide for patients and keep them safe,” Eugenia Gianos, MD, system director of cardiovascular prevention at Northwell Health and director of the Women’s Cardiovascular Center, Lenox Hill Hospital, New York, said in an interview. “Realistically, the whole digital realm has a lot of promise for our patients.” She noted that telehealth programs are still being developed for the department, but that office visits have been purposely scaled back by more than 75% to protect patients as well as health care providers. “In times of need, the most promising technologies we have, have to come to the forefront,” Dr. Gianos said. “So using the data from the home – whether they have a blood pressure cuff or something that tracks their heart rate or their weight – when we don’t otherwise have data, is of great value.”
Andrew M. Freeman, MD, director of clinical cardiology and operations at National Jewish Hospital in Denver, said “in the current situation, telehealth is the most viable option because it keeps patients safe and physicians safe. So it wouldn’t surprise me if every institution in the country, if not worldwide, is very rapidly pursuing this kind of approach.”
Exactly how many programs or cardiologists were already using telehealth is impossible to say, although the ACC is planning to survey its members on their practices during the COVID-19 pandemic, he noted.
The situation is so fluid that ACC is already revising its March 13 telehealth guidance to reflect the recent policy changes. Another document is being prepared to provide physicians with a template for the telehealth space, said Dr. Freeman, who coauthored the telehealth guidance and also serves on the ACC’s Innovation Leadership Council.
The new FDA policy allowing greater flexibility on remote monitoring devices is somewhat “vaguely worded,” Dr. Freeman noted, but highlights the ability of existing technology to provide essential patient data from home. “I think as we add adjuncts to the things we’re used to in the normal face-to-face visit, it’s going to make the face-to-face visit less required,” he said.
Questions remain, however, on implementing telehealth for new patients and whether payers will follow HHS’s decision not to conduct audits to ensure a prior relationship existed. The potential for telehealth to reach across state lines also is being viewed cautiously until tested legally, Dr. Freeman observed.
“If there’s one blessing in this awful disease that we have received, is that it may really give the power to clinicians, hospital systems, and payers to make telehealth a true viable, sustainable solution for good care that’s readily available to folks,” he said.
Fast-tracked research
On March 24, the American Heart Association announced it is committing $2.5 million for fast-tracked research grants for projects than can turn around results within 9-12 months and focus on how this novel coronavirus affects heart and brain health.
Additional funding also will be made available to the AHA’s new Center for Health Technology & Innovation’s Strategically Focused Research Networks to develop rapid technology solutions to aid in dealing with the pandemic.
The rapid response grant is an “unprecedented but logical move for the organization in these extraordinary times,” AHA President Bob Harrington, MD, chair of medicine at Stanford (Calif.) University, said in a statement. “We are committed to quickly bringing together and supporting some of the brightest minds in research science and clinical care who are shovel ready with the laboratories, tools, and data resources to immediately begin work on addressing this emergent issue.”
Dr. Freeman and Dr. Bhatt have disclosed no relevant financial relationships. Dr. Harrington is on the editorial board for Medscape Cardiology.
A version of this article originally appeared on Medscape.com
Is COVID-19 leading to a mental illness pandemic?
People living through this crisis are experiencing trauma
We are in the midst of an epidemic and possibly pandemic of anxiety and distress. The worry that folks have about themselves, families, finances, and work is overwhelming for millions.
I speak with people who report periods of racing thoughts jumping back in time and thinking of roads not taken. They also talk about their thoughts jumping forward with life plans of what they’ll do to change their lives in the future – if they survive COVID-19.
that is well-controlled with care (and even without care). Those people are suffering even more. Meanwhile, people with obsessive-compulsive disorder that had been under control appear to have worsened with the added stress.
Social distancing has disrupted our everyday routines. For many, there is no work, no spending time with people we care about, no going to movies or shows, no doing discretionary shopping, no going to school. Parents with children at home report frustration about balancing working from home with completing home-schooling packets. Physicians on the front lines of this unprecedented time report not having the proper protective equipment and worrying about the possibility of exposing their families to SARS-CoV-2.
We hear stories about the illness and even deaths of some young and middle-aged people with no underlying conditions, not to mention the loss of older adults. People are bursting into tears, and becoming easily frustrated and angry. Add in nightmares, ongoing anxiety states, insomnia, and decreased concentration.
We are seeing news reports of people stocking up on guns and ammunition and a case of one taking – and dying from – nonpharmaceutical grade chloroquine in an effort to prevent COVID-19.
I spoke with Juliana Tseng, PsyD, a clinical psychologist based in New York, and she said that the hype, half-truths, and false information from some outlets in the popular media are making things worse. Dr. Tseng added that the lack of coordination among local, state, and federal governments also is increasing fear and alienation.
As I see this period in time, my first thoughts are that we are witnessing a national epidemic of trauma. Specifically, what we have here is a clinical picture of PTSD.
PTSD is defined clearly as a traumatic disorder with a real or perceived fracture with life. Isolation (which we are creating as a way to “flatten the curve” or slow the spread of COVID-19), although that strategy is in our best personal and public health interests, is both painful and stressful. Frustration, flashbacks of past life experiences plus flashbacks of being ill are reported in people I’ve spoken with. Avoidance, even though it is planned in this instance, is part of the PTSD complex.
What can we as mental health professionals do to help alleviate this suffering?
First, of course, we must listen to the scientific experts and the data – and tell people to do the same. Most experts will say that COVID-19 is a mild or moderate illness for the vast majority of people. We also must encourage people to observe precautions outlined by the Centers for Disease Control and Prevention, such as distancing from people, hand washing, and avoiding those who are ill. Explain to people that, currently, there is no vaccine to prevent COVID-19. Treatment is mainly supportive, and some medication trials are being explored. However, we can empower people by helping them to develop skills aimed at increasing the ability to relax and focus on more positive aspects of life to break the chain of the stress and tension of anxiety as well as control the PTSD.
For more than 40 years, I have helped people master relaxation techniques and guided imagery. When taught properly, people are able to use these techniques on their own.
To begin, I teach people how to relax, using a simple three-point method:
- Get comfortable in a nice chair, and slowly count from one to three. At the count of one, do one thing: “roll your eyes up to the top of your head.”
- At the count of two, do two things, “close your lids on your eyes and take a deep breath.”
- At three, exhale slowly, relax your eyes, and concentrate on a restful feeling of floating.
- Do this for about 30 seconds to a minute.
- Count backward, from three to two to one and open your eyes.
The person will notice how nice and restful they will feel.
After that exercise, get the person to move to the graduate level and go beyond just relaxation. In the following exercise, people can go into a relaxed state by imagining a movie screen. Tell the person to do two things:
1. Look at the imagined movie screen and project on it any pleasant scene you wish; this is your screen. You will feel yourself becoming more and more relaxed. The person can do this one, two, three or whatever times a day. The exercise can last 1 minute or 5.
2. Incorporate the 1, 2, 3 relaxation described earlier, allowing yourself to float into this restful state and go to your movie screen. Now, on the screen, imagine a thick line down the center, and on the left side, project your worries and anxieties and fears. The idea is to see but not experience them. Then shift to the ride side of the screen, and again, visualize any pleasant scene you wish. Again, do this for 1 minute or 5 minutes, whatever works.
You will notice that the pleasant scene on the right will overcome the anxiety scene on the left, in that pleasantness, in most instances, overcomes anxiety. For many, these techniques have proved very useful – whether the problem is anxiety or fear – or both. In my experience, these techniques are a good beginning for controlling PTSD and successfully treating it.
We are in the midst of what could be the biggest public health crisis that America has faced since the 1918 pandemic, also known as the Spanish flu. The lockdowns, quarantines, and the myriad of other disruptions can lead to alienation. In fact, it would be strange for us not to experience strong emotions under these extreme conditions. Life will get better! In the meantime, let’s encourage people to hope, pray, and use relaxation techniques and guided imagery approaches to help control anxiety, worry, stress, and issues related to PTSD. These approaches can give our minds and bodies periods of relaxation and recovery, and ultimately, they can calm our minds.
Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.
People living through this crisis are experiencing trauma
People living through this crisis are experiencing trauma
We are in the midst of an epidemic and possibly pandemic of anxiety and distress. The worry that folks have about themselves, families, finances, and work is overwhelming for millions.
I speak with people who report periods of racing thoughts jumping back in time and thinking of roads not taken. They also talk about their thoughts jumping forward with life plans of what they’ll do to change their lives in the future – if they survive COVID-19.
that is well-controlled with care (and even without care). Those people are suffering even more. Meanwhile, people with obsessive-compulsive disorder that had been under control appear to have worsened with the added stress.
Social distancing has disrupted our everyday routines. For many, there is no work, no spending time with people we care about, no going to movies or shows, no doing discretionary shopping, no going to school. Parents with children at home report frustration about balancing working from home with completing home-schooling packets. Physicians on the front lines of this unprecedented time report not having the proper protective equipment and worrying about the possibility of exposing their families to SARS-CoV-2.
We hear stories about the illness and even deaths of some young and middle-aged people with no underlying conditions, not to mention the loss of older adults. People are bursting into tears, and becoming easily frustrated and angry. Add in nightmares, ongoing anxiety states, insomnia, and decreased concentration.
We are seeing news reports of people stocking up on guns and ammunition and a case of one taking – and dying from – nonpharmaceutical grade chloroquine in an effort to prevent COVID-19.
I spoke with Juliana Tseng, PsyD, a clinical psychologist based in New York, and she said that the hype, half-truths, and false information from some outlets in the popular media are making things worse. Dr. Tseng added that the lack of coordination among local, state, and federal governments also is increasing fear and alienation.
As I see this period in time, my first thoughts are that we are witnessing a national epidemic of trauma. Specifically, what we have here is a clinical picture of PTSD.
PTSD is defined clearly as a traumatic disorder with a real or perceived fracture with life. Isolation (which we are creating as a way to “flatten the curve” or slow the spread of COVID-19), although that strategy is in our best personal and public health interests, is both painful and stressful. Frustration, flashbacks of past life experiences plus flashbacks of being ill are reported in people I’ve spoken with. Avoidance, even though it is planned in this instance, is part of the PTSD complex.
What can we as mental health professionals do to help alleviate this suffering?
First, of course, we must listen to the scientific experts and the data – and tell people to do the same. Most experts will say that COVID-19 is a mild or moderate illness for the vast majority of people. We also must encourage people to observe precautions outlined by the Centers for Disease Control and Prevention, such as distancing from people, hand washing, and avoiding those who are ill. Explain to people that, currently, there is no vaccine to prevent COVID-19. Treatment is mainly supportive, and some medication trials are being explored. However, we can empower people by helping them to develop skills aimed at increasing the ability to relax and focus on more positive aspects of life to break the chain of the stress and tension of anxiety as well as control the PTSD.
For more than 40 years, I have helped people master relaxation techniques and guided imagery. When taught properly, people are able to use these techniques on their own.
To begin, I teach people how to relax, using a simple three-point method:
- Get comfortable in a nice chair, and slowly count from one to three. At the count of one, do one thing: “roll your eyes up to the top of your head.”
- At the count of two, do two things, “close your lids on your eyes and take a deep breath.”
- At three, exhale slowly, relax your eyes, and concentrate on a restful feeling of floating.
- Do this for about 30 seconds to a minute.
- Count backward, from three to two to one and open your eyes.
The person will notice how nice and restful they will feel.
After that exercise, get the person to move to the graduate level and go beyond just relaxation. In the following exercise, people can go into a relaxed state by imagining a movie screen. Tell the person to do two things:
1. Look at the imagined movie screen and project on it any pleasant scene you wish; this is your screen. You will feel yourself becoming more and more relaxed. The person can do this one, two, three or whatever times a day. The exercise can last 1 minute or 5.
2. Incorporate the 1, 2, 3 relaxation described earlier, allowing yourself to float into this restful state and go to your movie screen. Now, on the screen, imagine a thick line down the center, and on the left side, project your worries and anxieties and fears. The idea is to see but not experience them. Then shift to the ride side of the screen, and again, visualize any pleasant scene you wish. Again, do this for 1 minute or 5 minutes, whatever works.
You will notice that the pleasant scene on the right will overcome the anxiety scene on the left, in that pleasantness, in most instances, overcomes anxiety. For many, these techniques have proved very useful – whether the problem is anxiety or fear – or both. In my experience, these techniques are a good beginning for controlling PTSD and successfully treating it.
We are in the midst of what could be the biggest public health crisis that America has faced since the 1918 pandemic, also known as the Spanish flu. The lockdowns, quarantines, and the myriad of other disruptions can lead to alienation. In fact, it would be strange for us not to experience strong emotions under these extreme conditions. Life will get better! In the meantime, let’s encourage people to hope, pray, and use relaxation techniques and guided imagery approaches to help control anxiety, worry, stress, and issues related to PTSD. These approaches can give our minds and bodies periods of relaxation and recovery, and ultimately, they can calm our minds.
Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.
We are in the midst of an epidemic and possibly pandemic of anxiety and distress. The worry that folks have about themselves, families, finances, and work is overwhelming for millions.
I speak with people who report periods of racing thoughts jumping back in time and thinking of roads not taken. They also talk about their thoughts jumping forward with life plans of what they’ll do to change their lives in the future – if they survive COVID-19.
that is well-controlled with care (and even without care). Those people are suffering even more. Meanwhile, people with obsessive-compulsive disorder that had been under control appear to have worsened with the added stress.
Social distancing has disrupted our everyday routines. For many, there is no work, no spending time with people we care about, no going to movies or shows, no doing discretionary shopping, no going to school. Parents with children at home report frustration about balancing working from home with completing home-schooling packets. Physicians on the front lines of this unprecedented time report not having the proper protective equipment and worrying about the possibility of exposing their families to SARS-CoV-2.
We hear stories about the illness and even deaths of some young and middle-aged people with no underlying conditions, not to mention the loss of older adults. People are bursting into tears, and becoming easily frustrated and angry. Add in nightmares, ongoing anxiety states, insomnia, and decreased concentration.
We are seeing news reports of people stocking up on guns and ammunition and a case of one taking – and dying from – nonpharmaceutical grade chloroquine in an effort to prevent COVID-19.
I spoke with Juliana Tseng, PsyD, a clinical psychologist based in New York, and she said that the hype, half-truths, and false information from some outlets in the popular media are making things worse. Dr. Tseng added that the lack of coordination among local, state, and federal governments also is increasing fear and alienation.
As I see this period in time, my first thoughts are that we are witnessing a national epidemic of trauma. Specifically, what we have here is a clinical picture of PTSD.
PTSD is defined clearly as a traumatic disorder with a real or perceived fracture with life. Isolation (which we are creating as a way to “flatten the curve” or slow the spread of COVID-19), although that strategy is in our best personal and public health interests, is both painful and stressful. Frustration, flashbacks of past life experiences plus flashbacks of being ill are reported in people I’ve spoken with. Avoidance, even though it is planned in this instance, is part of the PTSD complex.
What can we as mental health professionals do to help alleviate this suffering?
First, of course, we must listen to the scientific experts and the data – and tell people to do the same. Most experts will say that COVID-19 is a mild or moderate illness for the vast majority of people. We also must encourage people to observe precautions outlined by the Centers for Disease Control and Prevention, such as distancing from people, hand washing, and avoiding those who are ill. Explain to people that, currently, there is no vaccine to prevent COVID-19. Treatment is mainly supportive, and some medication trials are being explored. However, we can empower people by helping them to develop skills aimed at increasing the ability to relax and focus on more positive aspects of life to break the chain of the stress and tension of anxiety as well as control the PTSD.
For more than 40 years, I have helped people master relaxation techniques and guided imagery. When taught properly, people are able to use these techniques on their own.
To begin, I teach people how to relax, using a simple three-point method:
- Get comfortable in a nice chair, and slowly count from one to three. At the count of one, do one thing: “roll your eyes up to the top of your head.”
- At the count of two, do two things, “close your lids on your eyes and take a deep breath.”
- At three, exhale slowly, relax your eyes, and concentrate on a restful feeling of floating.
- Do this for about 30 seconds to a minute.
- Count backward, from three to two to one and open your eyes.
The person will notice how nice and restful they will feel.
After that exercise, get the person to move to the graduate level and go beyond just relaxation. In the following exercise, people can go into a relaxed state by imagining a movie screen. Tell the person to do two things:
1. Look at the imagined movie screen and project on it any pleasant scene you wish; this is your screen. You will feel yourself becoming more and more relaxed. The person can do this one, two, three or whatever times a day. The exercise can last 1 minute or 5.
2. Incorporate the 1, 2, 3 relaxation described earlier, allowing yourself to float into this restful state and go to your movie screen. Now, on the screen, imagine a thick line down the center, and on the left side, project your worries and anxieties and fears. The idea is to see but not experience them. Then shift to the ride side of the screen, and again, visualize any pleasant scene you wish. Again, do this for 1 minute or 5 minutes, whatever works.
You will notice that the pleasant scene on the right will overcome the anxiety scene on the left, in that pleasantness, in most instances, overcomes anxiety. For many, these techniques have proved very useful – whether the problem is anxiety or fear – or both. In my experience, these techniques are a good beginning for controlling PTSD and successfully treating it.
We are in the midst of what could be the biggest public health crisis that America has faced since the 1918 pandemic, also known as the Spanish flu. The lockdowns, quarantines, and the myriad of other disruptions can lead to alienation. In fact, it would be strange for us not to experience strong emotions under these extreme conditions. Life will get better! In the meantime, let’s encourage people to hope, pray, and use relaxation techniques and guided imagery approaches to help control anxiety, worry, stress, and issues related to PTSD. These approaches can give our minds and bodies periods of relaxation and recovery, and ultimately, they can calm our minds.
Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.
How long is it safe to delay gynecologic cancer surgery?
As I write this column, there are more than 25,000 current cases of COVID-19 in the United States with an expected exponential rise in these numbers. Hospitals are issuing directives to cancel or postpone “elective” surgery to preserve the finite essential personal protective equipment (PPE), encourage social distancing, prevent exposure of at-risk patients within the hospital, and ensure bed and ventilator capacity for the impending surge in COVID-19 patients.
Many health systems have defined which surgeries they consider permissible, typically by using time parameters such as would not cause patient harm if not performed within 4 weeks, or 7 days, or 24 hours. This leaves surgeons in the unfamiliar position of rationing health care, a role with which, over the coming months, we may have to become increasingly comfortable. This is an enormous responsibility, the shift of resources between one population in need and another, and decisions should be based on data, not bias or hunch. We know that untreated cancer is life threatening, but there is a difference between untreated and delayed. What is a safe time to wait for gynecologic cancer surgery after diagnosis without negatively affecting survival from that cancer?
As I looked through my own upcoming surgical schedule, I sought guidance from the American College of Surgeons’ website, updated on March 17, 2020. In this site they tabulate an “Elective Surgery Acuity Scale” in which “most cancers” fit into tier 3a, which corresponds to high acuity surgery – “do not postpone.” This definition is fairly generalized and blunt; it does not account for the differences in cancers and occasional voluntary needs to postpone a patient’s cancer surgery for health optimization. There are limited data that measure the impact of surgical wait times on survival from gynecologic cancer. Most of this research is observational, and therefore, is influenced by confounders causing delay in surgery (e.g., comorbid conditions or socioeconomic factors that limit access to care). However, the current enforced delays are involuntary; driven by the system, not the patient; and access is universally restricted.
Endometrial cancer
Most data regarding outcomes and gynecologic cancer delay come from endometrial cancer. In 2016, Shalowitz et al. evaluated 182,000 endometrial cancer cases documented within the National Cancer Database (NCDB), which captures approximately 70% of cancer surgeries in the United States.1 They separated these patients into groups of low-grade (grade 1 and 2 endometrioid) and high-grade (grade 3 endometrioid and nonendometrioid) cancers, and evaluated the groups for their overall survival, stratified by the time period between diagnosis and surgery. Interestingly, those whose surgery was performed under 2 weeks from diagnosis had worse perioperative mortality and long-term survival. This seems to be a function of lack of medical optimization; low-volume, nonspecialized centers having less wait time; and the presentation of more advanced and symptomatic disease demanding a more urgent surgery. After those initial 2 weeks of worse outcomes, there was a period of stable outcomes and safety in waiting that extended up to 8 weeks for patients with low-grade cancers and up to 18 weeks for patients with high-grade cancers.
It may be counterintuitive to think that surgical delay affects patients with high-grade endometrial cancers less. These are more aggressive cancers, and there is patient and provider concern for metastatic spread with time elapsed. But an expedited surgery does not appear to be necessary for this group. The Shalowitz study demonstrated no risk for upstaging with surgical delay, meaning that advanced stage was not more likely to be identified in patients whose surgery was delayed, compared with those performed earlier. This observation suggests that the survival from high-grade endometrial cancers is largely determined by factors that cannot be controlled by the surgeon such as the stage at diagnosis, occult spread, and decreased responsiveness of the tumor to adjuvant therapy. In other words, fast-tracking these patients to surgery has limited influence on the outcomes for high-grade endometrial cancers.
For low-grade cancers, adverse outcomes were seen with a surgical delay of more than 8 weeks. But this may not have been caused by progression of disease (low-grade cancers also were not upstaged with delays), but rather may reflect that, in normal times, elective delays of more than 8 weeks are a function of necessary complex medical optimization of comorbidities (such as obesity-related disease). The survival that is measured by NCDB is not disease specific, and patients with comorbidities will be more likely to have impaired overall survival.
A systematic review of all papers that looked at endometrial cancer outcomes associated with surgical delay determined that it is reasonable to delay surgery for up to 8 weeks.2
Ovarian cancer
The data for ovarian cancer surgery is more limited. Most literature discusses the impact of delay in the time between surgery and the receipt of adjuvant chemotherapy, but there are limited data exploring how a delay in primary debulking negatively affects patients. This is perhaps because advanced ovarian cancer surgery rarely is delayed because of symptoms and apparent advanced stage at diagnosis. When a patient’s surgery does need to be voluntarily delayed, for example for medical optimization, there is the option of neoadjuvant chemotherapy (NACT) in which surgery is performed after three or more cycles of chemotherapy. NACT has been shown in multiple studies to have noninferior cancer outcomes, compared with primary debulking surgery.3,4
Perhaps in this current environment in which access to operating rooms and supplies is rationed, we should consider offering more, or all, patients NACT? Hospital stays after primary cytoreductive surgeries are typically 3-7 days in length, and these patients are at a higher risk, compared with other gynecologic cancer surgeries, of ICU admission and blood transfusions, both limited resources in this current environment. The disadvantage of this approach is that, while chemotherapy can keep patients out of the hospital so that they can practice social distancing, this particular therapy adds to the immunocompromised population. However, even patients who undergo primary surgical cytoreductive surgery will need to rapidly transition to immunosuppressive cytotoxic therapy; therefore it is unlikely that this can be avoided entirely during this time.
Lower genital tract cancers
Surgery for patients with lower genital tract cancers – such as cervical and vulvar cancer – also can probably be safely delayed for a 4-week period, and possibly longer. A Canadian retrospective study looked collectively at cervical, vaginal, and vulvar cancers evaluating for disease progression associated with delay to surgery, using 28 days as a benchmark for delayed surgery.5 They found no significant increased progression associated with surgical delay greater than 28 days. This study evaluated progression of cancer and did not measure cancer survival, although it is unlikely we would see impaired survival without a significant increase in disease progression.
We also can look to outcomes from delayed radical hysterectomy for stage I cervical cancer in pregnancy to provided us with some data. A retrospective cohort study observed no difference in survival when 28 women with early-stage cervical cancer who were diagnosed in pregnancy (average wait time 20 weeks from diagnosis to treatment) were compared with the outcomes of 52 matched nonpregnant control patients (average wait time 8 weeks). Their survival was 89% versus 94% respectively (P = .08).6
Summary
Synthesizing this data, it appears that, in an environment of competing needs and resources, it is reasonable and safe to delay surgery for patients with gynecologic cancers for 4-6 weeks and potentially longer. This includes patients with high-grade endometrial cancers. Clearly, these decisions should be individualized to patients and different health systems. For example, a patient who presents with a cancer-associated life-threatening bowel obstruction or hemorrhage may need an immediate intervention, and communities minimally affected by the coronavirus pandemic may have more allowances for surgery. With respect to patient anxiety, most patients with cancer are keen to have surgery promptly, and breaking the news to them that their surgery may be delayed because of institutional and public health needs will be difficult. However, the data support that this is likely safe.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no relevant financial disclosures. Email Dr. Rossi at [email protected].
References
1. Am J Obstet Gynecol 2017;216(3):268 e1-68 e18.
2. Eur J Obstet Gynecol Reprod Biol 2020;246:1-6. doi: 10.1016/j.ejogrb.2020.01.004.
3. N Engl J Med 2010;363(10):943-53.
4. Lancet 2015;386(9990):249-57.
5. J Obstet Gynaecol Can 2015;37(4):338-44.
6. Am J Obstet Gynecol 2017;216(3):276 e1-76 e6. doi: 10.1016/j.ajog.2016.10.034.
As I write this column, there are more than 25,000 current cases of COVID-19 in the United States with an expected exponential rise in these numbers. Hospitals are issuing directives to cancel or postpone “elective” surgery to preserve the finite essential personal protective equipment (PPE), encourage social distancing, prevent exposure of at-risk patients within the hospital, and ensure bed and ventilator capacity for the impending surge in COVID-19 patients.
Many health systems have defined which surgeries they consider permissible, typically by using time parameters such as would not cause patient harm if not performed within 4 weeks, or 7 days, or 24 hours. This leaves surgeons in the unfamiliar position of rationing health care, a role with which, over the coming months, we may have to become increasingly comfortable. This is an enormous responsibility, the shift of resources between one population in need and another, and decisions should be based on data, not bias or hunch. We know that untreated cancer is life threatening, but there is a difference between untreated and delayed. What is a safe time to wait for gynecologic cancer surgery after diagnosis without negatively affecting survival from that cancer?
As I looked through my own upcoming surgical schedule, I sought guidance from the American College of Surgeons’ website, updated on March 17, 2020. In this site they tabulate an “Elective Surgery Acuity Scale” in which “most cancers” fit into tier 3a, which corresponds to high acuity surgery – “do not postpone.” This definition is fairly generalized and blunt; it does not account for the differences in cancers and occasional voluntary needs to postpone a patient’s cancer surgery for health optimization. There are limited data that measure the impact of surgical wait times on survival from gynecologic cancer. Most of this research is observational, and therefore, is influenced by confounders causing delay in surgery (e.g., comorbid conditions or socioeconomic factors that limit access to care). However, the current enforced delays are involuntary; driven by the system, not the patient; and access is universally restricted.
Endometrial cancer
Most data regarding outcomes and gynecologic cancer delay come from endometrial cancer. In 2016, Shalowitz et al. evaluated 182,000 endometrial cancer cases documented within the National Cancer Database (NCDB), which captures approximately 70% of cancer surgeries in the United States.1 They separated these patients into groups of low-grade (grade 1 and 2 endometrioid) and high-grade (grade 3 endometrioid and nonendometrioid) cancers, and evaluated the groups for their overall survival, stratified by the time period between diagnosis and surgery. Interestingly, those whose surgery was performed under 2 weeks from diagnosis had worse perioperative mortality and long-term survival. This seems to be a function of lack of medical optimization; low-volume, nonspecialized centers having less wait time; and the presentation of more advanced and symptomatic disease demanding a more urgent surgery. After those initial 2 weeks of worse outcomes, there was a period of stable outcomes and safety in waiting that extended up to 8 weeks for patients with low-grade cancers and up to 18 weeks for patients with high-grade cancers.
It may be counterintuitive to think that surgical delay affects patients with high-grade endometrial cancers less. These are more aggressive cancers, and there is patient and provider concern for metastatic spread with time elapsed. But an expedited surgery does not appear to be necessary for this group. The Shalowitz study demonstrated no risk for upstaging with surgical delay, meaning that advanced stage was not more likely to be identified in patients whose surgery was delayed, compared with those performed earlier. This observation suggests that the survival from high-grade endometrial cancers is largely determined by factors that cannot be controlled by the surgeon such as the stage at diagnosis, occult spread, and decreased responsiveness of the tumor to adjuvant therapy. In other words, fast-tracking these patients to surgery has limited influence on the outcomes for high-grade endometrial cancers.
For low-grade cancers, adverse outcomes were seen with a surgical delay of more than 8 weeks. But this may not have been caused by progression of disease (low-grade cancers also were not upstaged with delays), but rather may reflect that, in normal times, elective delays of more than 8 weeks are a function of necessary complex medical optimization of comorbidities (such as obesity-related disease). The survival that is measured by NCDB is not disease specific, and patients with comorbidities will be more likely to have impaired overall survival.
A systematic review of all papers that looked at endometrial cancer outcomes associated with surgical delay determined that it is reasonable to delay surgery for up to 8 weeks.2
Ovarian cancer
The data for ovarian cancer surgery is more limited. Most literature discusses the impact of delay in the time between surgery and the receipt of adjuvant chemotherapy, but there are limited data exploring how a delay in primary debulking negatively affects patients. This is perhaps because advanced ovarian cancer surgery rarely is delayed because of symptoms and apparent advanced stage at diagnosis. When a patient’s surgery does need to be voluntarily delayed, for example for medical optimization, there is the option of neoadjuvant chemotherapy (NACT) in which surgery is performed after three or more cycles of chemotherapy. NACT has been shown in multiple studies to have noninferior cancer outcomes, compared with primary debulking surgery.3,4
Perhaps in this current environment in which access to operating rooms and supplies is rationed, we should consider offering more, or all, patients NACT? Hospital stays after primary cytoreductive surgeries are typically 3-7 days in length, and these patients are at a higher risk, compared with other gynecologic cancer surgeries, of ICU admission and blood transfusions, both limited resources in this current environment. The disadvantage of this approach is that, while chemotherapy can keep patients out of the hospital so that they can practice social distancing, this particular therapy adds to the immunocompromised population. However, even patients who undergo primary surgical cytoreductive surgery will need to rapidly transition to immunosuppressive cytotoxic therapy; therefore it is unlikely that this can be avoided entirely during this time.
Lower genital tract cancers
Surgery for patients with lower genital tract cancers – such as cervical and vulvar cancer – also can probably be safely delayed for a 4-week period, and possibly longer. A Canadian retrospective study looked collectively at cervical, vaginal, and vulvar cancers evaluating for disease progression associated with delay to surgery, using 28 days as a benchmark for delayed surgery.5 They found no significant increased progression associated with surgical delay greater than 28 days. This study evaluated progression of cancer and did not measure cancer survival, although it is unlikely we would see impaired survival without a significant increase in disease progression.
We also can look to outcomes from delayed radical hysterectomy for stage I cervical cancer in pregnancy to provided us with some data. A retrospective cohort study observed no difference in survival when 28 women with early-stage cervical cancer who were diagnosed in pregnancy (average wait time 20 weeks from diagnosis to treatment) were compared with the outcomes of 52 matched nonpregnant control patients (average wait time 8 weeks). Their survival was 89% versus 94% respectively (P = .08).6
Summary
Synthesizing this data, it appears that, in an environment of competing needs and resources, it is reasonable and safe to delay surgery for patients with gynecologic cancers for 4-6 weeks and potentially longer. This includes patients with high-grade endometrial cancers. Clearly, these decisions should be individualized to patients and different health systems. For example, a patient who presents with a cancer-associated life-threatening bowel obstruction or hemorrhage may need an immediate intervention, and communities minimally affected by the coronavirus pandemic may have more allowances for surgery. With respect to patient anxiety, most patients with cancer are keen to have surgery promptly, and breaking the news to them that their surgery may be delayed because of institutional and public health needs will be difficult. However, the data support that this is likely safe.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no relevant financial disclosures. Email Dr. Rossi at [email protected].
References
1. Am J Obstet Gynecol 2017;216(3):268 e1-68 e18.
2. Eur J Obstet Gynecol Reprod Biol 2020;246:1-6. doi: 10.1016/j.ejogrb.2020.01.004.
3. N Engl J Med 2010;363(10):943-53.
4. Lancet 2015;386(9990):249-57.
5. J Obstet Gynaecol Can 2015;37(4):338-44.
6. Am J Obstet Gynecol 2017;216(3):276 e1-76 e6. doi: 10.1016/j.ajog.2016.10.034.
As I write this column, there are more than 25,000 current cases of COVID-19 in the United States with an expected exponential rise in these numbers. Hospitals are issuing directives to cancel or postpone “elective” surgery to preserve the finite essential personal protective equipment (PPE), encourage social distancing, prevent exposure of at-risk patients within the hospital, and ensure bed and ventilator capacity for the impending surge in COVID-19 patients.
Many health systems have defined which surgeries they consider permissible, typically by using time parameters such as would not cause patient harm if not performed within 4 weeks, or 7 days, or 24 hours. This leaves surgeons in the unfamiliar position of rationing health care, a role with which, over the coming months, we may have to become increasingly comfortable. This is an enormous responsibility, the shift of resources between one population in need and another, and decisions should be based on data, not bias or hunch. We know that untreated cancer is life threatening, but there is a difference between untreated and delayed. What is a safe time to wait for gynecologic cancer surgery after diagnosis without negatively affecting survival from that cancer?
As I looked through my own upcoming surgical schedule, I sought guidance from the American College of Surgeons’ website, updated on March 17, 2020. In this site they tabulate an “Elective Surgery Acuity Scale” in which “most cancers” fit into tier 3a, which corresponds to high acuity surgery – “do not postpone.” This definition is fairly generalized and blunt; it does not account for the differences in cancers and occasional voluntary needs to postpone a patient’s cancer surgery for health optimization. There are limited data that measure the impact of surgical wait times on survival from gynecologic cancer. Most of this research is observational, and therefore, is influenced by confounders causing delay in surgery (e.g., comorbid conditions or socioeconomic factors that limit access to care). However, the current enforced delays are involuntary; driven by the system, not the patient; and access is universally restricted.
Endometrial cancer
Most data regarding outcomes and gynecologic cancer delay come from endometrial cancer. In 2016, Shalowitz et al. evaluated 182,000 endometrial cancer cases documented within the National Cancer Database (NCDB), which captures approximately 70% of cancer surgeries in the United States.1 They separated these patients into groups of low-grade (grade 1 and 2 endometrioid) and high-grade (grade 3 endometrioid and nonendometrioid) cancers, and evaluated the groups for their overall survival, stratified by the time period between diagnosis and surgery. Interestingly, those whose surgery was performed under 2 weeks from diagnosis had worse perioperative mortality and long-term survival. This seems to be a function of lack of medical optimization; low-volume, nonspecialized centers having less wait time; and the presentation of more advanced and symptomatic disease demanding a more urgent surgery. After those initial 2 weeks of worse outcomes, there was a period of stable outcomes and safety in waiting that extended up to 8 weeks for patients with low-grade cancers and up to 18 weeks for patients with high-grade cancers.
It may be counterintuitive to think that surgical delay affects patients with high-grade endometrial cancers less. These are more aggressive cancers, and there is patient and provider concern for metastatic spread with time elapsed. But an expedited surgery does not appear to be necessary for this group. The Shalowitz study demonstrated no risk for upstaging with surgical delay, meaning that advanced stage was not more likely to be identified in patients whose surgery was delayed, compared with those performed earlier. This observation suggests that the survival from high-grade endometrial cancers is largely determined by factors that cannot be controlled by the surgeon such as the stage at diagnosis, occult spread, and decreased responsiveness of the tumor to adjuvant therapy. In other words, fast-tracking these patients to surgery has limited influence on the outcomes for high-grade endometrial cancers.
For low-grade cancers, adverse outcomes were seen with a surgical delay of more than 8 weeks. But this may not have been caused by progression of disease (low-grade cancers also were not upstaged with delays), but rather may reflect that, in normal times, elective delays of more than 8 weeks are a function of necessary complex medical optimization of comorbidities (such as obesity-related disease). The survival that is measured by NCDB is not disease specific, and patients with comorbidities will be more likely to have impaired overall survival.
A systematic review of all papers that looked at endometrial cancer outcomes associated with surgical delay determined that it is reasonable to delay surgery for up to 8 weeks.2
Ovarian cancer
The data for ovarian cancer surgery is more limited. Most literature discusses the impact of delay in the time between surgery and the receipt of adjuvant chemotherapy, but there are limited data exploring how a delay in primary debulking negatively affects patients. This is perhaps because advanced ovarian cancer surgery rarely is delayed because of symptoms and apparent advanced stage at diagnosis. When a patient’s surgery does need to be voluntarily delayed, for example for medical optimization, there is the option of neoadjuvant chemotherapy (NACT) in which surgery is performed after three or more cycles of chemotherapy. NACT has been shown in multiple studies to have noninferior cancer outcomes, compared with primary debulking surgery.3,4
Perhaps in this current environment in which access to operating rooms and supplies is rationed, we should consider offering more, or all, patients NACT? Hospital stays after primary cytoreductive surgeries are typically 3-7 days in length, and these patients are at a higher risk, compared with other gynecologic cancer surgeries, of ICU admission and blood transfusions, both limited resources in this current environment. The disadvantage of this approach is that, while chemotherapy can keep patients out of the hospital so that they can practice social distancing, this particular therapy adds to the immunocompromised population. However, even patients who undergo primary surgical cytoreductive surgery will need to rapidly transition to immunosuppressive cytotoxic therapy; therefore it is unlikely that this can be avoided entirely during this time.
Lower genital tract cancers
Surgery for patients with lower genital tract cancers – such as cervical and vulvar cancer – also can probably be safely delayed for a 4-week period, and possibly longer. A Canadian retrospective study looked collectively at cervical, vaginal, and vulvar cancers evaluating for disease progression associated with delay to surgery, using 28 days as a benchmark for delayed surgery.5 They found no significant increased progression associated with surgical delay greater than 28 days. This study evaluated progression of cancer and did not measure cancer survival, although it is unlikely we would see impaired survival without a significant increase in disease progression.
We also can look to outcomes from delayed radical hysterectomy for stage I cervical cancer in pregnancy to provided us with some data. A retrospective cohort study observed no difference in survival when 28 women with early-stage cervical cancer who were diagnosed in pregnancy (average wait time 20 weeks from diagnosis to treatment) were compared with the outcomes of 52 matched nonpregnant control patients (average wait time 8 weeks). Their survival was 89% versus 94% respectively (P = .08).6
Summary
Synthesizing this data, it appears that, in an environment of competing needs and resources, it is reasonable and safe to delay surgery for patients with gynecologic cancers for 4-6 weeks and potentially longer. This includes patients with high-grade endometrial cancers. Clearly, these decisions should be individualized to patients and different health systems. For example, a patient who presents with a cancer-associated life-threatening bowel obstruction or hemorrhage may need an immediate intervention, and communities minimally affected by the coronavirus pandemic may have more allowances for surgery. With respect to patient anxiety, most patients with cancer are keen to have surgery promptly, and breaking the news to them that their surgery may be delayed because of institutional and public health needs will be difficult. However, the data support that this is likely safe.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no relevant financial disclosures. Email Dr. Rossi at [email protected].
References
1. Am J Obstet Gynecol 2017;216(3):268 e1-68 e18.
2. Eur J Obstet Gynecol Reprod Biol 2020;246:1-6. doi: 10.1016/j.ejogrb.2020.01.004.
3. N Engl J Med 2010;363(10):943-53.
4. Lancet 2015;386(9990):249-57.
5. J Obstet Gynaecol Can 2015;37(4):338-44.
6. Am J Obstet Gynecol 2017;216(3):276 e1-76 e6. doi: 10.1016/j.ajog.2016.10.034.
Cancer care and COVID-19 in Seattle, the first U.S. epicenter
Two months after the first patient with COVID-19 was identified in China, the first case was reported in the United States in the Seattle, Washington, metropolitan area.
Seattle rapidly became the first US epicenter for COVID-19, and local experts are now offering their expertise and advice on how to provide optimal cancer care during the pandemic in a special feature published online March 20 in the Journal of the National Comprehensive Cancer Network.
“We began implementing measures in early March, including infection control and screening of visitors, staff, and patients at the door,” said lead author Masumi Ueda, MD, who holds positions at the Seattle Cancer Care Alliance, the University of Washington, and the Fred Hutchinson Research Center.
“A lot of changes have been implemented, and it changes on a daily basis. We are responding to the growing rate of COVID-19 infection in the community,” she told Medscape Medical News.
Ueda notes that as a result of the quick implementation of new procedures, so far, very few cancer patients at their facilities have been infected by the virus. “It has not hit our cancer population hard, which is a good thing,” she said.
Create “Incident Command Structure”
In sharing their experience, the authors emphasize the importance of keeping channels of communication open between all stakeholders ― administrators and staff, patients, caregivers, and the general public. They also recommend that each facility create an “incident command structure” that can provide early coordination of institution-wide efforts and that can rapidly respond to changing information.
Ueda noted that their command structure was set up very early on, “so we could get communication set up and start building an infrastructure for response.”
Several areas of care that required new strategies were addressed, both to protect patients and to work around staff shortages caused by possible exposure and/or school closings, as well as projected shortages of supplies and hospital resources.
First and foremost was to identify patients and visitors who had respiratory symptoms and to provide them with masks. Although this is always routine practice during the respiratory virus season, screening has now been initiated at entry points throughout the system.
“We were lucky in Seattle and Washington state in that the University of Washington virology lab developed PCR [polymerase chain reaction] testing early on for COVID-19, which subsequently got FDA approval,” said Ueda. “So we were able to have local testing and didn’t have to rely on the state lab. Testing has also been rapidly scaled up.”
Initiating a comprehensive policy for testing staff, tracking results and exposures for persons under investigation, and defining when it is possible to return to work are essential elements for maintaining a stable workforce. In addition, reinforcing a strict “stay at home when ill” policy and providing access to testing for symptomatic staff have been key to limiting exposures.
“What is unique to our region is that we had testing early on, and we are turning it around in 24 hours,” she pointed out. “This is important for staff to be able to return to work.” Currently, staff, patients, and visitors are being tested only if they show the cardinal symptoms associated with COVID-19: fever, shortness of breath, and cough, although muscle aches have recently been added to their testing protocol.
“I think if we had unlimited capacity, we might consider testing people who are asymptomatic,” Ueda noted, “although if you don’t have symptoms, you may not have the viral load needed for an accurate test.”
Educational materials explaining infection control were also needed for patients and families, along with signs and a website to provide COVID-19 education. These were quickly developed.
In addition, a telephone triage line was established for patients with mild symptoms in order to minimize exposures in clinics and to lessen the number of patients presenting at emergency departments.
Outpatient Care
Because theirs is a referral center, many cancer patients come from out of town, and so there is concern about exposing nonlocal patients to COVID-19 as the virus spreads in the Seattle area. In addition, staffing shortages due to factors such as illness, exposure, and school closures are anticipated.
To address these problems, an initial priority was to establish a “multilayer” coverage system for the clinics in the event that practitioners had to be quarantined on short notice, the authors explain.
One decision was to reschedule all wellness visits for current patients or to use telemedicine. Capacity for that option expanded quickly, which was greatly helped by the recent decision by the Centers for Medicare & Medicaid Services to lift Medicare restrictions on the use of certain telemedicine services.
Another approach is to defer all consultations for second opinions for patients who were already undergoing treatment and to increase clinic hours of operations and capabilities for acute evaluations. This helps reserve emergency departments and hospital resources for patients who require higher-level care, the authors comment.
Treatment Decisions
Treatment decisions were more challenging to make, the authors note. One decision was that, despite the risk for COVID-19 for patients with solid tumors, adjuvant therapy with curative intent should proceed, they note. Similarly, patients with metastatic disease might lose the window of opportunity for treatment if it is delayed.
Treatment for aggressive hematologic malignancies is usually urgent, and stem cell transplant and cellular immunotherapies that provide curative treatments cannot be delayed in many cases.
Enrollment in clinical trials will most likely be limited to those trials that are most likely to benefit the patient.
Ueda noted that, because their patients come from all over the country, they are now conducting consultations for stem cell transplant by telephone so that nonlocal patients do not have to travel to Seattle. “If there is some way we can delay the treatment, we have taken that approach,” Ueda told Medscape Medical News. “If we can divert a patient to an area that is not as heavily affected, that’s another option we are taking.”
Although cancer surgery is not considered elective, surgical intervention needs to be prioritized, the authors comment. In the Seattle system, there is currently a 2-week ban on elective surgery in the healthcare system, owing to limited availability of personal protective equipment (PPE), staffing, and beds.
The oncology teams are currently reviewing treatment regimens to determine which treatments might lessen immunosuppression and which treatment options can be moved from the inpatient to the outpatient setting or can be delayed.
Inpatient Care
For hospitalized patients, several issues are being addressed. The priority is to prepare for an upcoming shortage of beds and resources because of the surge of patients with COVID-19 that is predicted. For both clinic and hospitalized patients, shortages of blood products have necessitated stricter adherence to thresholds for transfusion, and consideration is being given to lowering those thresholds.
Another important problem is the need to conserve PPE, which includes masks, gowns, gloves, and other products. The Seattle teams have implemented solutions such as favoring handwashing with soap and water over the use of hand gel for standard-precaution rooms, limiting the number of personnel entering patient rooms (so as to use less PPE), and reducing nursing procedures that require PPE, such as measuring urine output, unless they are necessary.
In addition, a no-visitor policy has been adopted in inpatient units to conserve PPE, with the exception of end-of-life situations.
The Future
The future trajectory of the COVID-19 pandemic is uncertain, Ueda commented. She emphasized that “we must continue to prepare for its widespread impact. The unknown is what we are looking at. We are expecting it to evolve, and the number of infections cannot go down.”
Ueda and coauthors end their article on a positive note. “To many of us, this has become the health care challenge of our generation, one that modern cancer therapy has never had to face. We will prevail, and when the pandemic ends, we will all be proud of what we did for our patients and each other in this critical moment for humanity.”
Two months after the first patient with COVID-19 was identified in China, the first case was reported in the United States in the Seattle, Washington, metropolitan area.
Seattle rapidly became the first US epicenter for COVID-19, and local experts are now offering their expertise and advice on how to provide optimal cancer care during the pandemic in a special feature published online March 20 in the Journal of the National Comprehensive Cancer Network.
“We began implementing measures in early March, including infection control and screening of visitors, staff, and patients at the door,” said lead author Masumi Ueda, MD, who holds positions at the Seattle Cancer Care Alliance, the University of Washington, and the Fred Hutchinson Research Center.
“A lot of changes have been implemented, and it changes on a daily basis. We are responding to the growing rate of COVID-19 infection in the community,” she told Medscape Medical News.
Ueda notes that as a result of the quick implementation of new procedures, so far, very few cancer patients at their facilities have been infected by the virus. “It has not hit our cancer population hard, which is a good thing,” she said.
Create “Incident Command Structure”
In sharing their experience, the authors emphasize the importance of keeping channels of communication open between all stakeholders ― administrators and staff, patients, caregivers, and the general public. They also recommend that each facility create an “incident command structure” that can provide early coordination of institution-wide efforts and that can rapidly respond to changing information.
Ueda noted that their command structure was set up very early on, “so we could get communication set up and start building an infrastructure for response.”
Several areas of care that required new strategies were addressed, both to protect patients and to work around staff shortages caused by possible exposure and/or school closings, as well as projected shortages of supplies and hospital resources.
First and foremost was to identify patients and visitors who had respiratory symptoms and to provide them with masks. Although this is always routine practice during the respiratory virus season, screening has now been initiated at entry points throughout the system.
“We were lucky in Seattle and Washington state in that the University of Washington virology lab developed PCR [polymerase chain reaction] testing early on for COVID-19, which subsequently got FDA approval,” said Ueda. “So we were able to have local testing and didn’t have to rely on the state lab. Testing has also been rapidly scaled up.”
Initiating a comprehensive policy for testing staff, tracking results and exposures for persons under investigation, and defining when it is possible to return to work are essential elements for maintaining a stable workforce. In addition, reinforcing a strict “stay at home when ill” policy and providing access to testing for symptomatic staff have been key to limiting exposures.
“What is unique to our region is that we had testing early on, and we are turning it around in 24 hours,” she pointed out. “This is important for staff to be able to return to work.” Currently, staff, patients, and visitors are being tested only if they show the cardinal symptoms associated with COVID-19: fever, shortness of breath, and cough, although muscle aches have recently been added to their testing protocol.
“I think if we had unlimited capacity, we might consider testing people who are asymptomatic,” Ueda noted, “although if you don’t have symptoms, you may not have the viral load needed for an accurate test.”
Educational materials explaining infection control were also needed for patients and families, along with signs and a website to provide COVID-19 education. These were quickly developed.
In addition, a telephone triage line was established for patients with mild symptoms in order to minimize exposures in clinics and to lessen the number of patients presenting at emergency departments.
Outpatient Care
Because theirs is a referral center, many cancer patients come from out of town, and so there is concern about exposing nonlocal patients to COVID-19 as the virus spreads in the Seattle area. In addition, staffing shortages due to factors such as illness, exposure, and school closures are anticipated.
To address these problems, an initial priority was to establish a “multilayer” coverage system for the clinics in the event that practitioners had to be quarantined on short notice, the authors explain.
One decision was to reschedule all wellness visits for current patients or to use telemedicine. Capacity for that option expanded quickly, which was greatly helped by the recent decision by the Centers for Medicare & Medicaid Services to lift Medicare restrictions on the use of certain telemedicine services.
Another approach is to defer all consultations for second opinions for patients who were already undergoing treatment and to increase clinic hours of operations and capabilities for acute evaluations. This helps reserve emergency departments and hospital resources for patients who require higher-level care, the authors comment.
Treatment Decisions
Treatment decisions were more challenging to make, the authors note. One decision was that, despite the risk for COVID-19 for patients with solid tumors, adjuvant therapy with curative intent should proceed, they note. Similarly, patients with metastatic disease might lose the window of opportunity for treatment if it is delayed.
Treatment for aggressive hematologic malignancies is usually urgent, and stem cell transplant and cellular immunotherapies that provide curative treatments cannot be delayed in many cases.
Enrollment in clinical trials will most likely be limited to those trials that are most likely to benefit the patient.
Ueda noted that, because their patients come from all over the country, they are now conducting consultations for stem cell transplant by telephone so that nonlocal patients do not have to travel to Seattle. “If there is some way we can delay the treatment, we have taken that approach,” Ueda told Medscape Medical News. “If we can divert a patient to an area that is not as heavily affected, that’s another option we are taking.”
Although cancer surgery is not considered elective, surgical intervention needs to be prioritized, the authors comment. In the Seattle system, there is currently a 2-week ban on elective surgery in the healthcare system, owing to limited availability of personal protective equipment (PPE), staffing, and beds.
The oncology teams are currently reviewing treatment regimens to determine which treatments might lessen immunosuppression and which treatment options can be moved from the inpatient to the outpatient setting or can be delayed.
Inpatient Care
For hospitalized patients, several issues are being addressed. The priority is to prepare for an upcoming shortage of beds and resources because of the surge of patients with COVID-19 that is predicted. For both clinic and hospitalized patients, shortages of blood products have necessitated stricter adherence to thresholds for transfusion, and consideration is being given to lowering those thresholds.
Another important problem is the need to conserve PPE, which includes masks, gowns, gloves, and other products. The Seattle teams have implemented solutions such as favoring handwashing with soap and water over the use of hand gel for standard-precaution rooms, limiting the number of personnel entering patient rooms (so as to use less PPE), and reducing nursing procedures that require PPE, such as measuring urine output, unless they are necessary.
In addition, a no-visitor policy has been adopted in inpatient units to conserve PPE, with the exception of end-of-life situations.
The Future
The future trajectory of the COVID-19 pandemic is uncertain, Ueda commented. She emphasized that “we must continue to prepare for its widespread impact. The unknown is what we are looking at. We are expecting it to evolve, and the number of infections cannot go down.”
Ueda and coauthors end their article on a positive note. “To many of us, this has become the health care challenge of our generation, one that modern cancer therapy has never had to face. We will prevail, and when the pandemic ends, we will all be proud of what we did for our patients and each other in this critical moment for humanity.”
Two months after the first patient with COVID-19 was identified in China, the first case was reported in the United States in the Seattle, Washington, metropolitan area.
Seattle rapidly became the first US epicenter for COVID-19, and local experts are now offering their expertise and advice on how to provide optimal cancer care during the pandemic in a special feature published online March 20 in the Journal of the National Comprehensive Cancer Network.
“We began implementing measures in early March, including infection control and screening of visitors, staff, and patients at the door,” said lead author Masumi Ueda, MD, who holds positions at the Seattle Cancer Care Alliance, the University of Washington, and the Fred Hutchinson Research Center.
“A lot of changes have been implemented, and it changes on a daily basis. We are responding to the growing rate of COVID-19 infection in the community,” she told Medscape Medical News.
Ueda notes that as a result of the quick implementation of new procedures, so far, very few cancer patients at their facilities have been infected by the virus. “It has not hit our cancer population hard, which is a good thing,” she said.
Create “Incident Command Structure”
In sharing their experience, the authors emphasize the importance of keeping channels of communication open between all stakeholders ― administrators and staff, patients, caregivers, and the general public. They also recommend that each facility create an “incident command structure” that can provide early coordination of institution-wide efforts and that can rapidly respond to changing information.
Ueda noted that their command structure was set up very early on, “so we could get communication set up and start building an infrastructure for response.”
Several areas of care that required new strategies were addressed, both to protect patients and to work around staff shortages caused by possible exposure and/or school closings, as well as projected shortages of supplies and hospital resources.
First and foremost was to identify patients and visitors who had respiratory symptoms and to provide them with masks. Although this is always routine practice during the respiratory virus season, screening has now been initiated at entry points throughout the system.
“We were lucky in Seattle and Washington state in that the University of Washington virology lab developed PCR [polymerase chain reaction] testing early on for COVID-19, which subsequently got FDA approval,” said Ueda. “So we were able to have local testing and didn’t have to rely on the state lab. Testing has also been rapidly scaled up.”
Initiating a comprehensive policy for testing staff, tracking results and exposures for persons under investigation, and defining when it is possible to return to work are essential elements for maintaining a stable workforce. In addition, reinforcing a strict “stay at home when ill” policy and providing access to testing for symptomatic staff have been key to limiting exposures.
“What is unique to our region is that we had testing early on, and we are turning it around in 24 hours,” she pointed out. “This is important for staff to be able to return to work.” Currently, staff, patients, and visitors are being tested only if they show the cardinal symptoms associated with COVID-19: fever, shortness of breath, and cough, although muscle aches have recently been added to their testing protocol.
“I think if we had unlimited capacity, we might consider testing people who are asymptomatic,” Ueda noted, “although if you don’t have symptoms, you may not have the viral load needed for an accurate test.”
Educational materials explaining infection control were also needed for patients and families, along with signs and a website to provide COVID-19 education. These were quickly developed.
In addition, a telephone triage line was established for patients with mild symptoms in order to minimize exposures in clinics and to lessen the number of patients presenting at emergency departments.
Outpatient Care
Because theirs is a referral center, many cancer patients come from out of town, and so there is concern about exposing nonlocal patients to COVID-19 as the virus spreads in the Seattle area. In addition, staffing shortages due to factors such as illness, exposure, and school closures are anticipated.
To address these problems, an initial priority was to establish a “multilayer” coverage system for the clinics in the event that practitioners had to be quarantined on short notice, the authors explain.
One decision was to reschedule all wellness visits for current patients or to use telemedicine. Capacity for that option expanded quickly, which was greatly helped by the recent decision by the Centers for Medicare & Medicaid Services to lift Medicare restrictions on the use of certain telemedicine services.
Another approach is to defer all consultations for second opinions for patients who were already undergoing treatment and to increase clinic hours of operations and capabilities for acute evaluations. This helps reserve emergency departments and hospital resources for patients who require higher-level care, the authors comment.
Treatment Decisions
Treatment decisions were more challenging to make, the authors note. One decision was that, despite the risk for COVID-19 for patients with solid tumors, adjuvant therapy with curative intent should proceed, they note. Similarly, patients with metastatic disease might lose the window of opportunity for treatment if it is delayed.
Treatment for aggressive hematologic malignancies is usually urgent, and stem cell transplant and cellular immunotherapies that provide curative treatments cannot be delayed in many cases.
Enrollment in clinical trials will most likely be limited to those trials that are most likely to benefit the patient.
Ueda noted that, because their patients come from all over the country, they are now conducting consultations for stem cell transplant by telephone so that nonlocal patients do not have to travel to Seattle. “If there is some way we can delay the treatment, we have taken that approach,” Ueda told Medscape Medical News. “If we can divert a patient to an area that is not as heavily affected, that’s another option we are taking.”
Although cancer surgery is not considered elective, surgical intervention needs to be prioritized, the authors comment. In the Seattle system, there is currently a 2-week ban on elective surgery in the healthcare system, owing to limited availability of personal protective equipment (PPE), staffing, and beds.
The oncology teams are currently reviewing treatment regimens to determine which treatments might lessen immunosuppression and which treatment options can be moved from the inpatient to the outpatient setting or can be delayed.
Inpatient Care
For hospitalized patients, several issues are being addressed. The priority is to prepare for an upcoming shortage of beds and resources because of the surge of patients with COVID-19 that is predicted. For both clinic and hospitalized patients, shortages of blood products have necessitated stricter adherence to thresholds for transfusion, and consideration is being given to lowering those thresholds.
Another important problem is the need to conserve PPE, which includes masks, gowns, gloves, and other products. The Seattle teams have implemented solutions such as favoring handwashing with soap and water over the use of hand gel for standard-precaution rooms, limiting the number of personnel entering patient rooms (so as to use less PPE), and reducing nursing procedures that require PPE, such as measuring urine output, unless they are necessary.
In addition, a no-visitor policy has been adopted in inpatient units to conserve PPE, with the exception of end-of-life situations.
The Future
The future trajectory of the COVID-19 pandemic is uncertain, Ueda commented. She emphasized that “we must continue to prepare for its widespread impact. The unknown is what we are looking at. We are expecting it to evolve, and the number of infections cannot go down.”
Ueda and coauthors end their article on a positive note. “To many of us, this has become the health care challenge of our generation, one that modern cancer therapy has never had to face. We will prevail, and when the pandemic ends, we will all be proud of what we did for our patients and each other in this critical moment for humanity.”
Preventable diseases could gain a foothold because of COVID-19
There is a highly infectious virus spreading around the world and it is targeting the most vulnerable among us. It is among the most contagious of human diseases, spreading through the air unseen. No, it isn’t the novel coronavirus, COVID-19. It’s measles.
Remember measles? Outbreaks in recent years have brought the disease, which once was declared eliminated in the United States, back into the news and public awareness, but measles never has really gone away. Every year there are millions of cases worldwide – in 2018 alone there were nearly 10 million estimated cases and 142,300 deaths, according to the World Health Organization. The good news is that measles vaccination is highly effective, at about 97% after the recommended two doses. According to the Centers for Disease Control and Prevention, “because of vaccination, more than 21 million lives have been saved and measles deaths have been reduced by 80% since 2000.” This is a tremendous public health success and a cause for celebration. But our work is not done. The recent increases in vaccine hesitancy and refusal in many countries has contributed to the resurgence of measles worldwide.
Influenza still is in full swing with the CDC reporting high activity in 1 states for the week ending April 4th. Seasonal influenza, according to currently available data, has a lower fatality rate than COVID-19, but that doesn’t mean it is harmless. Thus far in the 2019-2020 flu season, there have been at least 24,000 deaths because of influenza in the United States alone, 166 of which were among pediatric patients.*
Like many pediatricians, I have seen firsthand the impact of vaccine-preventable illnesses like influenza, pertussis, and varicella. I have personally cared for an infant with pertussis who had to be intubated and on a ventilator for nearly a week. I have told the family of a child with cancer that they would have to be admitted to the hospital yet again for intravenous antiviral medication because that little rash turned out to be varicella. I have performed CPR on a previously healthy teenager with the flu whose heart was failing despite maximum ventilator support. All these illnesses might have been prevented had these patients or those around them been appropriately vaccinated.
Right now, the United States and governments around the world are taking unprecedented public health measures to prevent the spread of COVID-19, directing the public to stay home, avoid unnecessary contact with other people, practice good hand-washing and infection-control techniques. In order to promote social distancing, many primary care clinics are canceling nonurgent appointments or converting them to virtual visits, including some visits for routine vaccinations for older children, teens, and adults. This is a responsible choice to keep potentially asymptomatic people from spreading COVID-19, but once restrictions begin to lift, we all will need to act to help our patients catch up on these missing vaccinations.
This pandemic has made it more apparent than ever that we all rely upon each other to stay healthy. While this pandemic has disrupted nearly every aspect of daily life, we can’t let it disrupt one of the great successes in health care today: the prevention of serious illnesses. As soon as it is safe to do so, we must help and encourage patients to catch up on missing vaccinations. It’s rare that preventative public health measures and vaccine developments are in the nightly news, so we should use this increased public awareness to ensure patients are well educated and protected from every disease. As part of this, we must continue our efforts to share accurate information on the safety and efficacy of routine vaccination. And when there is a vaccine for COVID-19? Let’s make sure everyone gets that too.
Dr. Leighton is a pediatrician in the ED at Children’s National Hospital and currently is completing her MPH in health policy at George Washington University, both in Washington. She had no relevant financial disclosures.*
* This article was updated 4/10/2020.
There is a highly infectious virus spreading around the world and it is targeting the most vulnerable among us. It is among the most contagious of human diseases, spreading through the air unseen. No, it isn’t the novel coronavirus, COVID-19. It’s measles.
Remember measles? Outbreaks in recent years have brought the disease, which once was declared eliminated in the United States, back into the news and public awareness, but measles never has really gone away. Every year there are millions of cases worldwide – in 2018 alone there were nearly 10 million estimated cases and 142,300 deaths, according to the World Health Organization. The good news is that measles vaccination is highly effective, at about 97% after the recommended two doses. According to the Centers for Disease Control and Prevention, “because of vaccination, more than 21 million lives have been saved and measles deaths have been reduced by 80% since 2000.” This is a tremendous public health success and a cause for celebration. But our work is not done. The recent increases in vaccine hesitancy and refusal in many countries has contributed to the resurgence of measles worldwide.
Influenza still is in full swing with the CDC reporting high activity in 1 states for the week ending April 4th. Seasonal influenza, according to currently available data, has a lower fatality rate than COVID-19, but that doesn’t mean it is harmless. Thus far in the 2019-2020 flu season, there have been at least 24,000 deaths because of influenza in the United States alone, 166 of which were among pediatric patients.*
Like many pediatricians, I have seen firsthand the impact of vaccine-preventable illnesses like influenza, pertussis, and varicella. I have personally cared for an infant with pertussis who had to be intubated and on a ventilator for nearly a week. I have told the family of a child with cancer that they would have to be admitted to the hospital yet again for intravenous antiviral medication because that little rash turned out to be varicella. I have performed CPR on a previously healthy teenager with the flu whose heart was failing despite maximum ventilator support. All these illnesses might have been prevented had these patients or those around them been appropriately vaccinated.
Right now, the United States and governments around the world are taking unprecedented public health measures to prevent the spread of COVID-19, directing the public to stay home, avoid unnecessary contact with other people, practice good hand-washing and infection-control techniques. In order to promote social distancing, many primary care clinics are canceling nonurgent appointments or converting them to virtual visits, including some visits for routine vaccinations for older children, teens, and adults. This is a responsible choice to keep potentially asymptomatic people from spreading COVID-19, but once restrictions begin to lift, we all will need to act to help our patients catch up on these missing vaccinations.
This pandemic has made it more apparent than ever that we all rely upon each other to stay healthy. While this pandemic has disrupted nearly every aspect of daily life, we can’t let it disrupt one of the great successes in health care today: the prevention of serious illnesses. As soon as it is safe to do so, we must help and encourage patients to catch up on missing vaccinations. It’s rare that preventative public health measures and vaccine developments are in the nightly news, so we should use this increased public awareness to ensure patients are well educated and protected from every disease. As part of this, we must continue our efforts to share accurate information on the safety and efficacy of routine vaccination. And when there is a vaccine for COVID-19? Let’s make sure everyone gets that too.
Dr. Leighton is a pediatrician in the ED at Children’s National Hospital and currently is completing her MPH in health policy at George Washington University, both in Washington. She had no relevant financial disclosures.*
* This article was updated 4/10/2020.
There is a highly infectious virus spreading around the world and it is targeting the most vulnerable among us. It is among the most contagious of human diseases, spreading through the air unseen. No, it isn’t the novel coronavirus, COVID-19. It’s measles.
Remember measles? Outbreaks in recent years have brought the disease, which once was declared eliminated in the United States, back into the news and public awareness, but measles never has really gone away. Every year there are millions of cases worldwide – in 2018 alone there were nearly 10 million estimated cases and 142,300 deaths, according to the World Health Organization. The good news is that measles vaccination is highly effective, at about 97% after the recommended two doses. According to the Centers for Disease Control and Prevention, “because of vaccination, more than 21 million lives have been saved and measles deaths have been reduced by 80% since 2000.” This is a tremendous public health success and a cause for celebration. But our work is not done. The recent increases in vaccine hesitancy and refusal in many countries has contributed to the resurgence of measles worldwide.
Influenza still is in full swing with the CDC reporting high activity in 1 states for the week ending April 4th. Seasonal influenza, according to currently available data, has a lower fatality rate than COVID-19, but that doesn’t mean it is harmless. Thus far in the 2019-2020 flu season, there have been at least 24,000 deaths because of influenza in the United States alone, 166 of which were among pediatric patients.*
Like many pediatricians, I have seen firsthand the impact of vaccine-preventable illnesses like influenza, pertussis, and varicella. I have personally cared for an infant with pertussis who had to be intubated and on a ventilator for nearly a week. I have told the family of a child with cancer that they would have to be admitted to the hospital yet again for intravenous antiviral medication because that little rash turned out to be varicella. I have performed CPR on a previously healthy teenager with the flu whose heart was failing despite maximum ventilator support. All these illnesses might have been prevented had these patients or those around them been appropriately vaccinated.
Right now, the United States and governments around the world are taking unprecedented public health measures to prevent the spread of COVID-19, directing the public to stay home, avoid unnecessary contact with other people, practice good hand-washing and infection-control techniques. In order to promote social distancing, many primary care clinics are canceling nonurgent appointments or converting them to virtual visits, including some visits for routine vaccinations for older children, teens, and adults. This is a responsible choice to keep potentially asymptomatic people from spreading COVID-19, but once restrictions begin to lift, we all will need to act to help our patients catch up on these missing vaccinations.
This pandemic has made it more apparent than ever that we all rely upon each other to stay healthy. While this pandemic has disrupted nearly every aspect of daily life, we can’t let it disrupt one of the great successes in health care today: the prevention of serious illnesses. As soon as it is safe to do so, we must help and encourage patients to catch up on missing vaccinations. It’s rare that preventative public health measures and vaccine developments are in the nightly news, so we should use this increased public awareness to ensure patients are well educated and protected from every disease. As part of this, we must continue our efforts to share accurate information on the safety and efficacy of routine vaccination. And when there is a vaccine for COVID-19? Let’s make sure everyone gets that too.
Dr. Leighton is a pediatrician in the ED at Children’s National Hospital and currently is completing her MPH in health policy at George Washington University, both in Washington. She had no relevant financial disclosures.*
* This article was updated 4/10/2020.
COVID-19 prompts ‘lifesaving’ policy change for opioid addiction
In the face of the US COVID-19 pandemic, the US Substance Abuse and Mental Health Services Administration (SAMHSA) has announced policy changes to allow some patients in opioid treatment programs (OTP) to take home their medication.
According to the agency, states may request “blanket exceptions” for all stable patients in an OTP to receive a 28-day supply of take-home doses of medications such as methadone and buprenorphine, which are used to treat opioid use disorder (OUD).
States may request up to 14 days of take-home medication for patients who are less stable but who can, in the judgment of OTP clinicians, safely handle this level of take-home medication.
“SAMHSA recognizes the evolving issues surrounding COVID-19 and the emerging needs OTPs continue to face,” the agency writes in its updated guidance.
“SAMHSA affirms its commitment to supporting OTPs in any way possible during this time. As such, we are expanding our previous guidance to provide increased flexibility,” the agency said.
A ‘Lifesaving’ Decision
Commenting on the SAMHSA policy change, Richard Saitz, MD, professor and chair of the department of community health sciences, Boston University School of Public Health, said, the policy “is not only a good idea, it is critical and lifesaving.”
“This approach had to be done now. With the reduction in face-to-face visits, patients with opioid use disorder need a way to access treatment. If they cannot get opioid agonists, they would withdraw and return to illicit opioid use and high overdose risk and it would be cruel,” said Saitz.
“It is possible that there will be some diversion and some risk of overdose or misuse, but even for less stable patients the benefit likely far outweighs the risk,” he told Medscape Medical News.
Saitz believes policy changes like this should have been made before a crisis.
“Honestly, this is perhaps a silver lining of the crisis” and could lead to permanent change in how OUD is treated in the US, he said.
“Just like we are learning what can be done without a medical in-person visit, we will learn that it is perfectly fine to treat patients with addiction more like we treat patients with other chronic diseases who take medication that has risks and benefits,” Saitz said.
in cases when a patient is quarantined because of coronavirus.
Typically, only licensed practitioners can dispense or administer OUD medications to patients, but during the COVID-19 crisis, treatment program staff members, law enforcement officers, and national guard personnel will be allowed to deliver OUD medications to an approved “lockbox” at the patient’s doorstep. The change applies only while the coronavirus public health emergency lasts.
“This is also an excellent idea,” Saitz said.
ASAM Also Responds
In addition, the American Society of Addiction Medicine (ASAM) released a focused update to its National Practice Guideline for the Treatment of Opioid Use Disorder (NPG).
The update is “especially critical in the context of the ongoing COVID-19 emergency, which threatens to curtail patient access to evidence-based treatment,” the organization said in a news release. The new document updates the 2015 NPG. It includes 13 new recommendations and major revisions to 35 existing recommendations.
One new recommendation states that comprehensive assessment of a patient is critical for treatment planning, but completing all assessments should not delay or preclude initiating pharmacotherapy for OUD. Another new recommendation states that there is no recommended time limit for pharmacotherapy.
ASAM continues to recommend that patients’ psychosocial needs be assessed and psychosocial treatment offered. However, if patients can’t access psychosocial treatment because they are in isolation or have other risk factors that preclude external interactions, clinicians should not delay initiation of medication for the treatment of addiction.
Expanding the use of telemedicine might also be appropriate for many patients, ASAM announced.
They note that the NPG is the first to address in a single document all medications currently approved by the US Food and Drug Administration to treat OUD and opioid withdrawal, including all available buprenorphine formulations.
“All of the updated recommendations are designed to both improve the quality and consistency of care and reduce barriers to access to care for Americans living with OUD. The updated recommendations aim to support initiation of buprenorphine treatment in the emergency department and other urgent care settings,” the society said in the release.
“In addition, [the recommendations] provide greater flexibility on dosing during the initiation of buprenorphine treatment and for initiation of buprenorphine at home (which is also an important change in the midst of the COVID-19 crisis).”
The full document is available online.
This article first appeared on Medscape.com.
In the face of the US COVID-19 pandemic, the US Substance Abuse and Mental Health Services Administration (SAMHSA) has announced policy changes to allow some patients in opioid treatment programs (OTP) to take home their medication.
According to the agency, states may request “blanket exceptions” for all stable patients in an OTP to receive a 28-day supply of take-home doses of medications such as methadone and buprenorphine, which are used to treat opioid use disorder (OUD).
States may request up to 14 days of take-home medication for patients who are less stable but who can, in the judgment of OTP clinicians, safely handle this level of take-home medication.
“SAMHSA recognizes the evolving issues surrounding COVID-19 and the emerging needs OTPs continue to face,” the agency writes in its updated guidance.
“SAMHSA affirms its commitment to supporting OTPs in any way possible during this time. As such, we are expanding our previous guidance to provide increased flexibility,” the agency said.
A ‘Lifesaving’ Decision
Commenting on the SAMHSA policy change, Richard Saitz, MD, professor and chair of the department of community health sciences, Boston University School of Public Health, said, the policy “is not only a good idea, it is critical and lifesaving.”
“This approach had to be done now. With the reduction in face-to-face visits, patients with opioid use disorder need a way to access treatment. If they cannot get opioid agonists, they would withdraw and return to illicit opioid use and high overdose risk and it would be cruel,” said Saitz.
“It is possible that there will be some diversion and some risk of overdose or misuse, but even for less stable patients the benefit likely far outweighs the risk,” he told Medscape Medical News.
Saitz believes policy changes like this should have been made before a crisis.
“Honestly, this is perhaps a silver lining of the crisis” and could lead to permanent change in how OUD is treated in the US, he said.
“Just like we are learning what can be done without a medical in-person visit, we will learn that it is perfectly fine to treat patients with addiction more like we treat patients with other chronic diseases who take medication that has risks and benefits,” Saitz said.
in cases when a patient is quarantined because of coronavirus.
Typically, only licensed practitioners can dispense or administer OUD medications to patients, but during the COVID-19 crisis, treatment program staff members, law enforcement officers, and national guard personnel will be allowed to deliver OUD medications to an approved “lockbox” at the patient’s doorstep. The change applies only while the coronavirus public health emergency lasts.
“This is also an excellent idea,” Saitz said.
ASAM Also Responds
In addition, the American Society of Addiction Medicine (ASAM) released a focused update to its National Practice Guideline for the Treatment of Opioid Use Disorder (NPG).
The update is “especially critical in the context of the ongoing COVID-19 emergency, which threatens to curtail patient access to evidence-based treatment,” the organization said in a news release. The new document updates the 2015 NPG. It includes 13 new recommendations and major revisions to 35 existing recommendations.
One new recommendation states that comprehensive assessment of a patient is critical for treatment planning, but completing all assessments should not delay or preclude initiating pharmacotherapy for OUD. Another new recommendation states that there is no recommended time limit for pharmacotherapy.
ASAM continues to recommend that patients’ psychosocial needs be assessed and psychosocial treatment offered. However, if patients can’t access psychosocial treatment because they are in isolation or have other risk factors that preclude external interactions, clinicians should not delay initiation of medication for the treatment of addiction.
Expanding the use of telemedicine might also be appropriate for many patients, ASAM announced.
They note that the NPG is the first to address in a single document all medications currently approved by the US Food and Drug Administration to treat OUD and opioid withdrawal, including all available buprenorphine formulations.
“All of the updated recommendations are designed to both improve the quality and consistency of care and reduce barriers to access to care for Americans living with OUD. The updated recommendations aim to support initiation of buprenorphine treatment in the emergency department and other urgent care settings,” the society said in the release.
“In addition, [the recommendations] provide greater flexibility on dosing during the initiation of buprenorphine treatment and for initiation of buprenorphine at home (which is also an important change in the midst of the COVID-19 crisis).”
The full document is available online.
This article first appeared on Medscape.com.
In the face of the US COVID-19 pandemic, the US Substance Abuse and Mental Health Services Administration (SAMHSA) has announced policy changes to allow some patients in opioid treatment programs (OTP) to take home their medication.
According to the agency, states may request “blanket exceptions” for all stable patients in an OTP to receive a 28-day supply of take-home doses of medications such as methadone and buprenorphine, which are used to treat opioid use disorder (OUD).
States may request up to 14 days of take-home medication for patients who are less stable but who can, in the judgment of OTP clinicians, safely handle this level of take-home medication.
“SAMHSA recognizes the evolving issues surrounding COVID-19 and the emerging needs OTPs continue to face,” the agency writes in its updated guidance.
“SAMHSA affirms its commitment to supporting OTPs in any way possible during this time. As such, we are expanding our previous guidance to provide increased flexibility,” the agency said.
A ‘Lifesaving’ Decision
Commenting on the SAMHSA policy change, Richard Saitz, MD, professor and chair of the department of community health sciences, Boston University School of Public Health, said, the policy “is not only a good idea, it is critical and lifesaving.”
“This approach had to be done now. With the reduction in face-to-face visits, patients with opioid use disorder need a way to access treatment. If they cannot get opioid agonists, they would withdraw and return to illicit opioid use and high overdose risk and it would be cruel,” said Saitz.
“It is possible that there will be some diversion and some risk of overdose or misuse, but even for less stable patients the benefit likely far outweighs the risk,” he told Medscape Medical News.
Saitz believes policy changes like this should have been made before a crisis.
“Honestly, this is perhaps a silver lining of the crisis” and could lead to permanent change in how OUD is treated in the US, he said.
“Just like we are learning what can be done without a medical in-person visit, we will learn that it is perfectly fine to treat patients with addiction more like we treat patients with other chronic diseases who take medication that has risks and benefits,” Saitz said.
in cases when a patient is quarantined because of coronavirus.
Typically, only licensed practitioners can dispense or administer OUD medications to patients, but during the COVID-19 crisis, treatment program staff members, law enforcement officers, and national guard personnel will be allowed to deliver OUD medications to an approved “lockbox” at the patient’s doorstep. The change applies only while the coronavirus public health emergency lasts.
“This is also an excellent idea,” Saitz said.
ASAM Also Responds
In addition, the American Society of Addiction Medicine (ASAM) released a focused update to its National Practice Guideline for the Treatment of Opioid Use Disorder (NPG).
The update is “especially critical in the context of the ongoing COVID-19 emergency, which threatens to curtail patient access to evidence-based treatment,” the organization said in a news release. The new document updates the 2015 NPG. It includes 13 new recommendations and major revisions to 35 existing recommendations.
One new recommendation states that comprehensive assessment of a patient is critical for treatment planning, but completing all assessments should not delay or preclude initiating pharmacotherapy for OUD. Another new recommendation states that there is no recommended time limit for pharmacotherapy.
ASAM continues to recommend that patients’ psychosocial needs be assessed and psychosocial treatment offered. However, if patients can’t access psychosocial treatment because they are in isolation or have other risk factors that preclude external interactions, clinicians should not delay initiation of medication for the treatment of addiction.
Expanding the use of telemedicine might also be appropriate for many patients, ASAM announced.
They note that the NPG is the first to address in a single document all medications currently approved by the US Food and Drug Administration to treat OUD and opioid withdrawal, including all available buprenorphine formulations.
“All of the updated recommendations are designed to both improve the quality and consistency of care and reduce barriers to access to care for Americans living with OUD. The updated recommendations aim to support initiation of buprenorphine treatment in the emergency department and other urgent care settings,” the society said in the release.
“In addition, [the recommendations] provide greater flexibility on dosing during the initiation of buprenorphine treatment and for initiation of buprenorphine at home (which is also an important change in the midst of the COVID-19 crisis).”
The full document is available online.
This article first appeared on Medscape.com.
COVID-19: U.S. cardiology groups reaffirm continued use of RAAS-active drugs
Controversy continued over the potential effect of drugs that interfere with the renin-angiotensin-aldosterone system via the angiotensin-converting enzymes (ACE) may have on exacerbating infection with the SARS-CoV-2 virus that causes COVID-19.
A joint statement from the American Heart Association, American College of Cardiology, and the Heart Failure Society of America on March 17 gave full, unqualified support to maintaining patients on drugs that work this way, specifically the ACE inhibitors and angiotensin-receptor blockers (ARBs), which together form a long-standing cornerstone of treatment for hypertension, heart failure, and ischemic heart disease.
The three societies “recommend continuation” of ACE inhibitors or ARBs “for all patients already prescribed.” The statement went on to say that patients already diagnosed with a COVID-19 infection “should be fully evaluated before adding or removing any treatments, and any changes to their treatment should be based on the latest scientific evidence and shared decision making with their physician and health care team.”
“We understand the concern – as it has become clear that people with cardiovascular disease are at much higher risk of serious complications including death from COVID-19. However, we have reviewed the latest research – the evidence does not confirm the need to discontinue ACE inhibitors or ARBs, and we strongly recommend all physicians to consider the individual needs of each patient before making any changes to ACE-inhibitor or ARB treatment regimens,” said Robert A. Harrington, MD, president of the American Heart Association and professor and chair of medicine at Stanford (Calif.) University, in the statement.
“There are no experimental or clinical data demonstrating beneficial or adverse outcomes among COVID-19 patients using ACE-inhibitor or ARB medications,” added Richard J. Kovacs, MD, president of the American College of Cardiology and professor of cardiology at Indiana University in Indianapolis.
The “latest research” referred to in the statement likely focuses on a report that had appeared less than a week earlier in a British journal that hypothesized a possible increase in the susceptibility of human epithelial cells of the lungs, intestine, kidneys, and blood vessels exposed to these or certain other drugs, like the thiazolidinedione oral diabetes drugs or ibuprofen, because they cause up-regulation of the ACE2 protein in cell membranes, and ACE2 is the primary cell-surface receptor that allows the SARS-CoV-2 virus to enter.
“We therefore hypothesize that diabetes and hypertension treatment with ACE2-stimulating drugs increases the risk of developing severe and fatal COVID-19,” wrote Michael Roth, MD, and his associates in their recent article (Lancet Resp Med. 2020 Mar 11. doi: 10.1016/S2213-2600[20]30116-8). While the potential clinical impact of an increase in the number of ACE2 molecules in a cell’s surface membrane remains uninvestigated, the risk this phenomenon poses should mean that patients taking these drugs should receive heightened monitoring for COVID-19 disease, suggested Dr. Roth, a professor of biomedicine who specializes in studying inflammatory lung diseases including asthma, and associates.
However, others who have considered the impact that ACE inhibitors and ARBs might have on ACE2 and COVID-19 infections have noted that the picture is not simple. “Higher ACE2 expression following chronically medicating SARS‐CoV‐2 infected patients with AT1R [angiotensin receptor 1] blockers, while seemingly paradoxical, may protect them against acute lung injury rather than putting them at higher risk to develop SARS. This may be accounted for by two complementary mechanisms: blocking the excessive angiotensin‐mediated AT1R activation caused by the viral infection, as well as up-regulating ACE2, thereby reducing angiotensin production by ACE and increasing the production” of a vasodilating form of angiotensin, wrote David Gurwitz, PhD, in a recently published editorial (Drug Dev Res. 2020 Mar 4. doi: 10.1002/ddr.21656). A data-mining approach may allow researchers to determine whether patients who received drugs that interfere with angiotensin 1 function prior to being diagnosed with a COVID-19 infection had a better disease outcome, suggested Dr. Gurwitz, a molecular geneticist at Tel Aviv University in Jerusalem.
The statement from the three U.S. cardiology societies came a few days following a similar statement of support for ongoing use of ACE inhibitors and ARBs from the European Society of Cardiology’s Council on Hypertension.
Dr. Harrington, Dr. Kovacs, Dr. Roth, and Dr. Gurwitz had no relevant disclosures.
Controversy continued over the potential effect of drugs that interfere with the renin-angiotensin-aldosterone system via the angiotensin-converting enzymes (ACE) may have on exacerbating infection with the SARS-CoV-2 virus that causes COVID-19.
A joint statement from the American Heart Association, American College of Cardiology, and the Heart Failure Society of America on March 17 gave full, unqualified support to maintaining patients on drugs that work this way, specifically the ACE inhibitors and angiotensin-receptor blockers (ARBs), which together form a long-standing cornerstone of treatment for hypertension, heart failure, and ischemic heart disease.
The three societies “recommend continuation” of ACE inhibitors or ARBs “for all patients already prescribed.” The statement went on to say that patients already diagnosed with a COVID-19 infection “should be fully evaluated before adding or removing any treatments, and any changes to their treatment should be based on the latest scientific evidence and shared decision making with their physician and health care team.”
“We understand the concern – as it has become clear that people with cardiovascular disease are at much higher risk of serious complications including death from COVID-19. However, we have reviewed the latest research – the evidence does not confirm the need to discontinue ACE inhibitors or ARBs, and we strongly recommend all physicians to consider the individual needs of each patient before making any changes to ACE-inhibitor or ARB treatment regimens,” said Robert A. Harrington, MD, president of the American Heart Association and professor and chair of medicine at Stanford (Calif.) University, in the statement.
“There are no experimental or clinical data demonstrating beneficial or adverse outcomes among COVID-19 patients using ACE-inhibitor or ARB medications,” added Richard J. Kovacs, MD, president of the American College of Cardiology and professor of cardiology at Indiana University in Indianapolis.
The “latest research” referred to in the statement likely focuses on a report that had appeared less than a week earlier in a British journal that hypothesized a possible increase in the susceptibility of human epithelial cells of the lungs, intestine, kidneys, and blood vessels exposed to these or certain other drugs, like the thiazolidinedione oral diabetes drugs or ibuprofen, because they cause up-regulation of the ACE2 protein in cell membranes, and ACE2 is the primary cell-surface receptor that allows the SARS-CoV-2 virus to enter.
“We therefore hypothesize that diabetes and hypertension treatment with ACE2-stimulating drugs increases the risk of developing severe and fatal COVID-19,” wrote Michael Roth, MD, and his associates in their recent article (Lancet Resp Med. 2020 Mar 11. doi: 10.1016/S2213-2600[20]30116-8). While the potential clinical impact of an increase in the number of ACE2 molecules in a cell’s surface membrane remains uninvestigated, the risk this phenomenon poses should mean that patients taking these drugs should receive heightened monitoring for COVID-19 disease, suggested Dr. Roth, a professor of biomedicine who specializes in studying inflammatory lung diseases including asthma, and associates.
However, others who have considered the impact that ACE inhibitors and ARBs might have on ACE2 and COVID-19 infections have noted that the picture is not simple. “Higher ACE2 expression following chronically medicating SARS‐CoV‐2 infected patients with AT1R [angiotensin receptor 1] blockers, while seemingly paradoxical, may protect them against acute lung injury rather than putting them at higher risk to develop SARS. This may be accounted for by two complementary mechanisms: blocking the excessive angiotensin‐mediated AT1R activation caused by the viral infection, as well as up-regulating ACE2, thereby reducing angiotensin production by ACE and increasing the production” of a vasodilating form of angiotensin, wrote David Gurwitz, PhD, in a recently published editorial (Drug Dev Res. 2020 Mar 4. doi: 10.1002/ddr.21656). A data-mining approach may allow researchers to determine whether patients who received drugs that interfere with angiotensin 1 function prior to being diagnosed with a COVID-19 infection had a better disease outcome, suggested Dr. Gurwitz, a molecular geneticist at Tel Aviv University in Jerusalem.
The statement from the three U.S. cardiology societies came a few days following a similar statement of support for ongoing use of ACE inhibitors and ARBs from the European Society of Cardiology’s Council on Hypertension.
Dr. Harrington, Dr. Kovacs, Dr. Roth, and Dr. Gurwitz had no relevant disclosures.
Controversy continued over the potential effect of drugs that interfere with the renin-angiotensin-aldosterone system via the angiotensin-converting enzymes (ACE) may have on exacerbating infection with the SARS-CoV-2 virus that causes COVID-19.
A joint statement from the American Heart Association, American College of Cardiology, and the Heart Failure Society of America on March 17 gave full, unqualified support to maintaining patients on drugs that work this way, specifically the ACE inhibitors and angiotensin-receptor blockers (ARBs), which together form a long-standing cornerstone of treatment for hypertension, heart failure, and ischemic heart disease.
The three societies “recommend continuation” of ACE inhibitors or ARBs “for all patients already prescribed.” The statement went on to say that patients already diagnosed with a COVID-19 infection “should be fully evaluated before adding or removing any treatments, and any changes to their treatment should be based on the latest scientific evidence and shared decision making with their physician and health care team.”
“We understand the concern – as it has become clear that people with cardiovascular disease are at much higher risk of serious complications including death from COVID-19. However, we have reviewed the latest research – the evidence does not confirm the need to discontinue ACE inhibitors or ARBs, and we strongly recommend all physicians to consider the individual needs of each patient before making any changes to ACE-inhibitor or ARB treatment regimens,” said Robert A. Harrington, MD, president of the American Heart Association and professor and chair of medicine at Stanford (Calif.) University, in the statement.
“There are no experimental or clinical data demonstrating beneficial or adverse outcomes among COVID-19 patients using ACE-inhibitor or ARB medications,” added Richard J. Kovacs, MD, president of the American College of Cardiology and professor of cardiology at Indiana University in Indianapolis.
The “latest research” referred to in the statement likely focuses on a report that had appeared less than a week earlier in a British journal that hypothesized a possible increase in the susceptibility of human epithelial cells of the lungs, intestine, kidneys, and blood vessels exposed to these or certain other drugs, like the thiazolidinedione oral diabetes drugs or ibuprofen, because they cause up-regulation of the ACE2 protein in cell membranes, and ACE2 is the primary cell-surface receptor that allows the SARS-CoV-2 virus to enter.
“We therefore hypothesize that diabetes and hypertension treatment with ACE2-stimulating drugs increases the risk of developing severe and fatal COVID-19,” wrote Michael Roth, MD, and his associates in their recent article (Lancet Resp Med. 2020 Mar 11. doi: 10.1016/S2213-2600[20]30116-8). While the potential clinical impact of an increase in the number of ACE2 molecules in a cell’s surface membrane remains uninvestigated, the risk this phenomenon poses should mean that patients taking these drugs should receive heightened monitoring for COVID-19 disease, suggested Dr. Roth, a professor of biomedicine who specializes in studying inflammatory lung diseases including asthma, and associates.
However, others who have considered the impact that ACE inhibitors and ARBs might have on ACE2 and COVID-19 infections have noted that the picture is not simple. “Higher ACE2 expression following chronically medicating SARS‐CoV‐2 infected patients with AT1R [angiotensin receptor 1] blockers, while seemingly paradoxical, may protect them against acute lung injury rather than putting them at higher risk to develop SARS. This may be accounted for by two complementary mechanisms: blocking the excessive angiotensin‐mediated AT1R activation caused by the viral infection, as well as up-regulating ACE2, thereby reducing angiotensin production by ACE and increasing the production” of a vasodilating form of angiotensin, wrote David Gurwitz, PhD, in a recently published editorial (Drug Dev Res. 2020 Mar 4. doi: 10.1002/ddr.21656). A data-mining approach may allow researchers to determine whether patients who received drugs that interfere with angiotensin 1 function prior to being diagnosed with a COVID-19 infection had a better disease outcome, suggested Dr. Gurwitz, a molecular geneticist at Tel Aviv University in Jerusalem.
The statement from the three U.S. cardiology societies came a few days following a similar statement of support for ongoing use of ACE inhibitors and ARBs from the European Society of Cardiology’s Council on Hypertension.
Dr. Harrington, Dr. Kovacs, Dr. Roth, and Dr. Gurwitz had no relevant disclosures.
COVID-19 guidance for children’s health care providers
We are in uncharted waters with national and local states of emergency, schools and most activities being shut down, and rapidly evolving strategies on managing the COVID-19 outbreak. Everyone’s anxiety is appropriately high. As health care providers for children, you are facing changes in your personal life at home and in practice, likely including setting up televisits, trying to assess which patients to see, managing staffing challenges, and facing potential cash flow issues as expenses continue but revenue may fall short. And, of course, you will address a host of novel questions and concerns from the families you care for.
Your top priorities are to stay calm while offering clear recommendations on testing, quarantine, and treatment with guidance from our federal and local public health agencies. By providing clear guidance on the medical issues, you will offer substantial reassurance to families. But even with a medical plan in place, this remains a confusing and anxiety-provoking moment, one without much precedent in most people’s lives or in our national experience. Our aim is to complement that guidance by offering you some principles to help families manage the stress and anxiety that the disruptions and uncertainties that this public health emergency has created.
Offer clear, open, regular, and child-centered communication
If you have an email mailing list of your parents, you may want to summarize information you are gathering with a note they can expect at a specified time each day. You could request them to email you questions that then can be included as an FAQ (frequently asked questions).
Most children will have noticed people wearing face masks, or dramatic scenes on the news with hospital workers in full protective gear, breathlessly reporting growing numbers of the infected and the deceased. At a minimum, they are being commanded to wash hands and to not touch their faces (which is challenging enough for adults!), and are probably overhearing conversations about quarantines and contagion as well as family concerns about jobs and family finances. Many children are managing extended school closures and some are even managing the quarantine or serious illness of a loved one. When children overhear frightening news from distressed adults, they are going to become anxious and afraid themselves. Parents should remember to find out what their children have seen, heard, or understood about what is going on, and they should correct misinformation or misunderstandings with clear explanations. They also should find out what their children are curious about. “What has you wondering about that?” is a great response when children have questions, in order to make sure you get at any underlying worry.
It is fine to not have an answer to every question. It is difficult to offer clear explanations about something that we don’t yet fully understand, and it is fine to acknowledge what we don’t know. “That’s a great question. Let’s look together at the CDC [Centers for Disease Control and Prevention] website.” Offering to look for answers or information together can be a powerful way to model how to handle uncertainty. And always couch answers with appropriate (not false) reassurance: “Children and young adults appear to be very safe from this illness, but we want to take care to protect those that are older or already sick.”
Remember most children set their anxiety level based on their parent’s anxiety, and part of being child centered in your communication includes offering information in an age-appropriate manner. Preschool-aged children (up to 5 years) still have magical thinking. They are prone to finding masks and gowns scary and to assume that school stopping may be because they did something wrong. Tell them about the new illness, and about the doctors and officials working hard to keep people safe. Reassure them about all of the adults working hard together to understand the illness and take care of people who are sick. Their sense of time is less logical, so you may have to tell them more than once. Reassure them that children do not get very sick from this illness, but they can carry and spread it, like having paint on their hands, so they need to wash their hands often to take good care of other people.
School-age children (aged roughly 5-12 years) are better equipped cognitively to understand the seriousness of this outbreak. They are built to master new situations, but are prone to anxiety as they don’t yet have the emotional maturity to tolerate uncertainty or unfairness. Explain what is known without euphemisms, be truly curious about what their questions are, and look for answers together. Often what they need is to see you being calm in the face of uncertainty, bearing the strong feelings that may come, and preserving curiosity and compassion for others.
Adolescents also will need all of this support, and can be curious about more abstract implications (political, ethical, financial). Do not be surprised when they ask sophisticated questions, but still are focused on the personal disruptions or sacrifices (a canceled dance or sports meet, concerns about academic performance). Adolescence is a time of intense preoccupation with their emerging identity and relationships; it is normal for them to experience events in a way that may seem selfish, especially if it disrupts their time with friends. Remind parents to offer compassion and validation, while acknowledging that shared sacrifice and discomfort are a part of every individual’s experience when a society must respond to such a large challenge.
Be mindful of children’s vulnerabilities
Being child centered goes beyond thinking about their age and developmental stage. Parents are the experts on their children and will know about any particular vulnerabilities to the stresses of this serious outbreak. Children who are prone to anxiety or suffer from anxiety disorders may be more prone to silent worry. It is especially important to check in with them often, find out what they know and what they are worried about, and remind them to “never worry alone.” It also is important to continue with any recommended treatment, avoiding accommodation of their anxieties, except when it is required by public health protocols (i.e., staying home from school). Children with developmental disabilities may require additional support to change behaviors (hand washing) and may be more sensitive to changes in routine. And children with learning disabilities or special services in school may require additional support or structure during a prolonged period at home.
Preserve routines and structure
Routines and predictability are important to the sense of stability and well-being of most children (and adults). While disruptions are unavoidable, preserve what routines you can, and establish some new ones. For children who are out of school for several weeks, set up a consistent home routine, with a similar wake-up and bedtime, and a “school schedule.” There may be academic activities like reading or work sheets. If the parents’ work is disrupted, they can homeschool, shoring up weak academic areas or enhancing areas of interest. Be sure to preserve time for physical activity and social connections within this new framework. Social time does not require physical proximity, and can happen by screen or phone. Physical activity should be outside if at all possible. Predictability, preserved expectations (academic and otherwise), physical exercise, social connection, and consistent sleep will go a long way in protecting everyone’s ability to manage the disruptions of this epidemic.
Find opportunity in the disruption
Many families have been on a treadmill of work, school, and activities that have left little unscheduled time or spontaneity. Recommend looking at this disruption as a rare opportunity to slow down, spend time together, listen, learn more about one another, and even to have fun. Families could play board games, card games, watch movies together, or even read aloud. They might discover it is the time to try new hobbies (knitting, learning a new language or instrument), or to teach each other new skills. You might learn something new, or something new about your children. You also will offer a model of finding the opportunity in adversity, and even offer them some wonderful memories from a difficult time.
Take care of the vulnerable and ease others’ hardships
Without a doubt, this will be a difficult time for many people, medically, financially, and emotionally. One powerful strategy to build resilience in our children and strengthen our communities is to think with children about ways to help those who are most at risk or burdened by this challenge. Perhaps they want to make cards or FaceTime calls to older relatives who may be otherwise isolated. They may want to consider ways to support the work of first responders, even just with appreciation. They may want to reach out to elderly neighbors and offer to get groceries or other needed supplies for them. Balancing appropriate self-care with a focus on the needs of those who are more vulnerable or burdened than ourselves is a powerful way to show our children how communities pull together in a challenging time; enhance their feeling of connectedness; and build resilience in them, in our families, and in our communities.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected]
We are in uncharted waters with national and local states of emergency, schools and most activities being shut down, and rapidly evolving strategies on managing the COVID-19 outbreak. Everyone’s anxiety is appropriately high. As health care providers for children, you are facing changes in your personal life at home and in practice, likely including setting up televisits, trying to assess which patients to see, managing staffing challenges, and facing potential cash flow issues as expenses continue but revenue may fall short. And, of course, you will address a host of novel questions and concerns from the families you care for.
Your top priorities are to stay calm while offering clear recommendations on testing, quarantine, and treatment with guidance from our federal and local public health agencies. By providing clear guidance on the medical issues, you will offer substantial reassurance to families. But even with a medical plan in place, this remains a confusing and anxiety-provoking moment, one without much precedent in most people’s lives or in our national experience. Our aim is to complement that guidance by offering you some principles to help families manage the stress and anxiety that the disruptions and uncertainties that this public health emergency has created.
Offer clear, open, regular, and child-centered communication
If you have an email mailing list of your parents, you may want to summarize information you are gathering with a note they can expect at a specified time each day. You could request them to email you questions that then can be included as an FAQ (frequently asked questions).
Most children will have noticed people wearing face masks, or dramatic scenes on the news with hospital workers in full protective gear, breathlessly reporting growing numbers of the infected and the deceased. At a minimum, they are being commanded to wash hands and to not touch their faces (which is challenging enough for adults!), and are probably overhearing conversations about quarantines and contagion as well as family concerns about jobs and family finances. Many children are managing extended school closures and some are even managing the quarantine or serious illness of a loved one. When children overhear frightening news from distressed adults, they are going to become anxious and afraid themselves. Parents should remember to find out what their children have seen, heard, or understood about what is going on, and they should correct misinformation or misunderstandings with clear explanations. They also should find out what their children are curious about. “What has you wondering about that?” is a great response when children have questions, in order to make sure you get at any underlying worry.
It is fine to not have an answer to every question. It is difficult to offer clear explanations about something that we don’t yet fully understand, and it is fine to acknowledge what we don’t know. “That’s a great question. Let’s look together at the CDC [Centers for Disease Control and Prevention] website.” Offering to look for answers or information together can be a powerful way to model how to handle uncertainty. And always couch answers with appropriate (not false) reassurance: “Children and young adults appear to be very safe from this illness, but we want to take care to protect those that are older or already sick.”
Remember most children set their anxiety level based on their parent’s anxiety, and part of being child centered in your communication includes offering information in an age-appropriate manner. Preschool-aged children (up to 5 years) still have magical thinking. They are prone to finding masks and gowns scary and to assume that school stopping may be because they did something wrong. Tell them about the new illness, and about the doctors and officials working hard to keep people safe. Reassure them about all of the adults working hard together to understand the illness and take care of people who are sick. Their sense of time is less logical, so you may have to tell them more than once. Reassure them that children do not get very sick from this illness, but they can carry and spread it, like having paint on their hands, so they need to wash their hands often to take good care of other people.
School-age children (aged roughly 5-12 years) are better equipped cognitively to understand the seriousness of this outbreak. They are built to master new situations, but are prone to anxiety as they don’t yet have the emotional maturity to tolerate uncertainty or unfairness. Explain what is known without euphemisms, be truly curious about what their questions are, and look for answers together. Often what they need is to see you being calm in the face of uncertainty, bearing the strong feelings that may come, and preserving curiosity and compassion for others.
Adolescents also will need all of this support, and can be curious about more abstract implications (political, ethical, financial). Do not be surprised when they ask sophisticated questions, but still are focused on the personal disruptions or sacrifices (a canceled dance or sports meet, concerns about academic performance). Adolescence is a time of intense preoccupation with their emerging identity and relationships; it is normal for them to experience events in a way that may seem selfish, especially if it disrupts their time with friends. Remind parents to offer compassion and validation, while acknowledging that shared sacrifice and discomfort are a part of every individual’s experience when a society must respond to such a large challenge.
Be mindful of children’s vulnerabilities
Being child centered goes beyond thinking about their age and developmental stage. Parents are the experts on their children and will know about any particular vulnerabilities to the stresses of this serious outbreak. Children who are prone to anxiety or suffer from anxiety disorders may be more prone to silent worry. It is especially important to check in with them often, find out what they know and what they are worried about, and remind them to “never worry alone.” It also is important to continue with any recommended treatment, avoiding accommodation of their anxieties, except when it is required by public health protocols (i.e., staying home from school). Children with developmental disabilities may require additional support to change behaviors (hand washing) and may be more sensitive to changes in routine. And children with learning disabilities or special services in school may require additional support or structure during a prolonged period at home.
Preserve routines and structure
Routines and predictability are important to the sense of stability and well-being of most children (and adults). While disruptions are unavoidable, preserve what routines you can, and establish some new ones. For children who are out of school for several weeks, set up a consistent home routine, with a similar wake-up and bedtime, and a “school schedule.” There may be academic activities like reading or work sheets. If the parents’ work is disrupted, they can homeschool, shoring up weak academic areas or enhancing areas of interest. Be sure to preserve time for physical activity and social connections within this new framework. Social time does not require physical proximity, and can happen by screen or phone. Physical activity should be outside if at all possible. Predictability, preserved expectations (academic and otherwise), physical exercise, social connection, and consistent sleep will go a long way in protecting everyone’s ability to manage the disruptions of this epidemic.
Find opportunity in the disruption
Many families have been on a treadmill of work, school, and activities that have left little unscheduled time or spontaneity. Recommend looking at this disruption as a rare opportunity to slow down, spend time together, listen, learn more about one another, and even to have fun. Families could play board games, card games, watch movies together, or even read aloud. They might discover it is the time to try new hobbies (knitting, learning a new language or instrument), or to teach each other new skills. You might learn something new, or something new about your children. You also will offer a model of finding the opportunity in adversity, and even offer them some wonderful memories from a difficult time.
Take care of the vulnerable and ease others’ hardships
Without a doubt, this will be a difficult time for many people, medically, financially, and emotionally. One powerful strategy to build resilience in our children and strengthen our communities is to think with children about ways to help those who are most at risk or burdened by this challenge. Perhaps they want to make cards or FaceTime calls to older relatives who may be otherwise isolated. They may want to consider ways to support the work of first responders, even just with appreciation. They may want to reach out to elderly neighbors and offer to get groceries or other needed supplies for them. Balancing appropriate self-care with a focus on the needs of those who are more vulnerable or burdened than ourselves is a powerful way to show our children how communities pull together in a challenging time; enhance their feeling of connectedness; and build resilience in them, in our families, and in our communities.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected]
We are in uncharted waters with national and local states of emergency, schools and most activities being shut down, and rapidly evolving strategies on managing the COVID-19 outbreak. Everyone’s anxiety is appropriately high. As health care providers for children, you are facing changes in your personal life at home and in practice, likely including setting up televisits, trying to assess which patients to see, managing staffing challenges, and facing potential cash flow issues as expenses continue but revenue may fall short. And, of course, you will address a host of novel questions and concerns from the families you care for.
Your top priorities are to stay calm while offering clear recommendations on testing, quarantine, and treatment with guidance from our federal and local public health agencies. By providing clear guidance on the medical issues, you will offer substantial reassurance to families. But even with a medical plan in place, this remains a confusing and anxiety-provoking moment, one without much precedent in most people’s lives or in our national experience. Our aim is to complement that guidance by offering you some principles to help families manage the stress and anxiety that the disruptions and uncertainties that this public health emergency has created.
Offer clear, open, regular, and child-centered communication
If you have an email mailing list of your parents, you may want to summarize information you are gathering with a note they can expect at a specified time each day. You could request them to email you questions that then can be included as an FAQ (frequently asked questions).
Most children will have noticed people wearing face masks, or dramatic scenes on the news with hospital workers in full protective gear, breathlessly reporting growing numbers of the infected and the deceased. At a minimum, they are being commanded to wash hands and to not touch their faces (which is challenging enough for adults!), and are probably overhearing conversations about quarantines and contagion as well as family concerns about jobs and family finances. Many children are managing extended school closures and some are even managing the quarantine or serious illness of a loved one. When children overhear frightening news from distressed adults, they are going to become anxious and afraid themselves. Parents should remember to find out what their children have seen, heard, or understood about what is going on, and they should correct misinformation or misunderstandings with clear explanations. They also should find out what their children are curious about. “What has you wondering about that?” is a great response when children have questions, in order to make sure you get at any underlying worry.
It is fine to not have an answer to every question. It is difficult to offer clear explanations about something that we don’t yet fully understand, and it is fine to acknowledge what we don’t know. “That’s a great question. Let’s look together at the CDC [Centers for Disease Control and Prevention] website.” Offering to look for answers or information together can be a powerful way to model how to handle uncertainty. And always couch answers with appropriate (not false) reassurance: “Children and young adults appear to be very safe from this illness, but we want to take care to protect those that are older or already sick.”
Remember most children set their anxiety level based on their parent’s anxiety, and part of being child centered in your communication includes offering information in an age-appropriate manner. Preschool-aged children (up to 5 years) still have magical thinking. They are prone to finding masks and gowns scary and to assume that school stopping may be because they did something wrong. Tell them about the new illness, and about the doctors and officials working hard to keep people safe. Reassure them about all of the adults working hard together to understand the illness and take care of people who are sick. Their sense of time is less logical, so you may have to tell them more than once. Reassure them that children do not get very sick from this illness, but they can carry and spread it, like having paint on their hands, so they need to wash their hands often to take good care of other people.
School-age children (aged roughly 5-12 years) are better equipped cognitively to understand the seriousness of this outbreak. They are built to master new situations, but are prone to anxiety as they don’t yet have the emotional maturity to tolerate uncertainty or unfairness. Explain what is known without euphemisms, be truly curious about what their questions are, and look for answers together. Often what they need is to see you being calm in the face of uncertainty, bearing the strong feelings that may come, and preserving curiosity and compassion for others.
Adolescents also will need all of this support, and can be curious about more abstract implications (political, ethical, financial). Do not be surprised when they ask sophisticated questions, but still are focused on the personal disruptions or sacrifices (a canceled dance or sports meet, concerns about academic performance). Adolescence is a time of intense preoccupation with their emerging identity and relationships; it is normal for them to experience events in a way that may seem selfish, especially if it disrupts their time with friends. Remind parents to offer compassion and validation, while acknowledging that shared sacrifice and discomfort are a part of every individual’s experience when a society must respond to such a large challenge.
Be mindful of children’s vulnerabilities
Being child centered goes beyond thinking about their age and developmental stage. Parents are the experts on their children and will know about any particular vulnerabilities to the stresses of this serious outbreak. Children who are prone to anxiety or suffer from anxiety disorders may be more prone to silent worry. It is especially important to check in with them often, find out what they know and what they are worried about, and remind them to “never worry alone.” It also is important to continue with any recommended treatment, avoiding accommodation of their anxieties, except when it is required by public health protocols (i.e., staying home from school). Children with developmental disabilities may require additional support to change behaviors (hand washing) and may be more sensitive to changes in routine. And children with learning disabilities or special services in school may require additional support or structure during a prolonged period at home.
Preserve routines and structure
Routines and predictability are important to the sense of stability and well-being of most children (and adults). While disruptions are unavoidable, preserve what routines you can, and establish some new ones. For children who are out of school for several weeks, set up a consistent home routine, with a similar wake-up and bedtime, and a “school schedule.” There may be academic activities like reading or work sheets. If the parents’ work is disrupted, they can homeschool, shoring up weak academic areas or enhancing areas of interest. Be sure to preserve time for physical activity and social connections within this new framework. Social time does not require physical proximity, and can happen by screen or phone. Physical activity should be outside if at all possible. Predictability, preserved expectations (academic and otherwise), physical exercise, social connection, and consistent sleep will go a long way in protecting everyone’s ability to manage the disruptions of this epidemic.
Find opportunity in the disruption
Many families have been on a treadmill of work, school, and activities that have left little unscheduled time or spontaneity. Recommend looking at this disruption as a rare opportunity to slow down, spend time together, listen, learn more about one another, and even to have fun. Families could play board games, card games, watch movies together, or even read aloud. They might discover it is the time to try new hobbies (knitting, learning a new language or instrument), or to teach each other new skills. You might learn something new, or something new about your children. You also will offer a model of finding the opportunity in adversity, and even offer them some wonderful memories from a difficult time.
Take care of the vulnerable and ease others’ hardships
Without a doubt, this will be a difficult time for many people, medically, financially, and emotionally. One powerful strategy to build resilience in our children and strengthen our communities is to think with children about ways to help those who are most at risk or burdened by this challenge. Perhaps they want to make cards or FaceTime calls to older relatives who may be otherwise isolated. They may want to consider ways to support the work of first responders, even just with appreciation. They may want to reach out to elderly neighbors and offer to get groceries or other needed supplies for them. Balancing appropriate self-care with a focus on the needs of those who are more vulnerable or burdened than ourselves is a powerful way to show our children how communities pull together in a challenging time; enhance their feeling of connectedness; and build resilience in them, in our families, and in our communities.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected]
Physicians and health systems can reduce fear around COVID-19
A message from a Chief Wellness Officer
We are at a time, unfortunately, of significant public uncertainty and fear of “the coronavirus.” Mixed and inaccurate messages from national leaders in the setting of delayed testing availability have heightened fears and impeded a uniformity in responses, medical and preventive.
Despite this, physicians, nurses, and other health professionals across the country, and in many other countries, have been addressing the medical realities of this pandemic in a way that should make every one of us health professionals proud – from the Chinese doctors and nurses to the Italian intensivists and primary care physicians throughout many countries who have treated patients suffering from, or fearful of, a novel disease with uncertain transmission characteristics and unpredictable clinical outcomes.
It is now time for physicians and other health providers in the United States to step up to the plate and model appropriate transmission-reducing behavior for the general public. This will help reduce the overall morbidity and mortality associated with this pandemic and let us return to a more normal lifestyle as soon as possible. Physicians need to be reassuring but realistic, and there are concrete steps that we can take to demonstrate to the general public that there is a way forward.
First the basic facts. The United States does not have enough intensive care beds or ventilators to handle a major pandemic. We will also have insufficient physicians and nurses if many are quarantined. The tragic experience in Italy, where patients are dying from lack of ventilators, intensive care facilities, and staff, must not be repeated here.
Many health systems are canceling or reducing outpatient appointments and increasingly using video and other telehealth technologies, especially for assessing and triaging people who believe that they may have become infected and are relatively asymptomatic. While all of the disruptions may seem unsettling, they are actually good news for those of us in healthcare. Efforts to “flatten the curve” will slow the infection spread and help us better manage patients who become critical.
So, what can physicians do?
- Make sure you are getting good information about the situation. Access reliable information and data that are widely available through the Centers for Disease Control and Prevention, the National Institutes of Health, and the World Health Organization. Listen to professional news organizations, local and national. Pass this information to your patients and community.
- Obviously, when practicing clinically, follow all infection control protocols, which will inevitably change over time. Make it clear to your patients why you are following these protocols and procedures.
- Support and actively promote the public health responses to this pandemic. Systematic reviews of the evidence base have found that isolating ill persons, testing and tracing contacts, quarantining exposed persons, closing schools and workplaces, and avoiding crowding are more effective if implemented immediately, simultaneously (ie, school closures combined with teleworking for parents), and with high community compliance.
- Practice social distancing so that you remain as much in control as you can. This will make you feel psychologically better and safer, as well as reduce the risk for transmission. Take the essential precautionary measures that we are all being asked to take. Wash your hands. Do not shake hands. Clean shared items. Do not go to large public gatherings. Minimize large group travel as much as you can. Use video to see your patients or your own doctor.
- Connect and reconnect with people you trust and love. See your family, your partner, your children, your friends. Speak to them on the phone and nourish those relationships. See how they feel and care for each other. They will be worried about you. Reassure them. Be in the moment with them and use the importance of these relationships to give yourself a chance not to overthink any fears you might have.
- Look after yourself physically. Physical fitness is good for your mental health. While White House guidelines suggest avoiding gyms, you can still enjoy long walks and outdoor activities. Take the weekend off and don’t work excessively. Sleep well – at least 7-8 hours. which has a series of really excellent meditation and relaxation tools.
- Do not panic. Uncertainty surrounding the pandemic makes all of us anxious and afraid. It is normal to become hypervigilant, especially with our nonstop media. It is normal to be concerned when we feel out of control and when we are hearing about a possible future catastrophe, especially when fed with differing sets of information from multiple sources and countries.
- Be careful with any large decisions you are making that may affect the lives of yourself and your loved ones. Think about your decisions and try to take the long view; and run them by your spouse, partner, or friends. This is not a time to be making sudden big decisions that may be driven unconsciously, in part at least, by fear and anxiety.
- Realize that all of these societal disruptions are actually good for us in health care, and they help your family and friends understand the importance of slowing the disease’s spread. That’s good for health care and good for everyone.
Finally, remember that “this is what we do,” to quote Doug Kirk, MD, chief medical officer of UC Davis Health. We must look after our patients. But we also have to look after ourselves so that we can look after our patients. We should all be proud of our work and our caring. And we should model our personal behavior to our patients and to our families and friends so that they will model it to their community networks. That way, more people will keep well, and we will have more chance of “flattening the curve” and reducing the morbidity and mortality associated with COVID-19.
Peter M. Yellowlees, MBBS, MD, is a professor in the Department of Psychiatry at the University of California, Davis. He is a longtime Medscape contributor.
This article first appeared on Medscape.com.
A message from a Chief Wellness Officer
We are at a time, unfortunately, of significant public uncertainty and fear of “the coronavirus.” Mixed and inaccurate messages from national leaders in the setting of delayed testing availability have heightened fears and impeded a uniformity in responses, medical and preventive.
Despite this, physicians, nurses, and other health professionals across the country, and in many other countries, have been addressing the medical realities of this pandemic in a way that should make every one of us health professionals proud – from the Chinese doctors and nurses to the Italian intensivists and primary care physicians throughout many countries who have treated patients suffering from, or fearful of, a novel disease with uncertain transmission characteristics and unpredictable clinical outcomes.
It is now time for physicians and other health providers in the United States to step up to the plate and model appropriate transmission-reducing behavior for the general public. This will help reduce the overall morbidity and mortality associated with this pandemic and let us return to a more normal lifestyle as soon as possible. Physicians need to be reassuring but realistic, and there are concrete steps that we can take to demonstrate to the general public that there is a way forward.
First the basic facts. The United States does not have enough intensive care beds or ventilators to handle a major pandemic. We will also have insufficient physicians and nurses if many are quarantined. The tragic experience in Italy, where patients are dying from lack of ventilators, intensive care facilities, and staff, must not be repeated here.
Many health systems are canceling or reducing outpatient appointments and increasingly using video and other telehealth technologies, especially for assessing and triaging people who believe that they may have become infected and are relatively asymptomatic. While all of the disruptions may seem unsettling, they are actually good news for those of us in healthcare. Efforts to “flatten the curve” will slow the infection spread and help us better manage patients who become critical.
So, what can physicians do?
- Make sure you are getting good information about the situation. Access reliable information and data that are widely available through the Centers for Disease Control and Prevention, the National Institutes of Health, and the World Health Organization. Listen to professional news organizations, local and national. Pass this information to your patients and community.
- Obviously, when practicing clinically, follow all infection control protocols, which will inevitably change over time. Make it clear to your patients why you are following these protocols and procedures.
- Support and actively promote the public health responses to this pandemic. Systematic reviews of the evidence base have found that isolating ill persons, testing and tracing contacts, quarantining exposed persons, closing schools and workplaces, and avoiding crowding are more effective if implemented immediately, simultaneously (ie, school closures combined with teleworking for parents), and with high community compliance.
- Practice social distancing so that you remain as much in control as you can. This will make you feel psychologically better and safer, as well as reduce the risk for transmission. Take the essential precautionary measures that we are all being asked to take. Wash your hands. Do not shake hands. Clean shared items. Do not go to large public gatherings. Minimize large group travel as much as you can. Use video to see your patients or your own doctor.
- Connect and reconnect with people you trust and love. See your family, your partner, your children, your friends. Speak to them on the phone and nourish those relationships. See how they feel and care for each other. They will be worried about you. Reassure them. Be in the moment with them and use the importance of these relationships to give yourself a chance not to overthink any fears you might have.
- Look after yourself physically. Physical fitness is good for your mental health. While White House guidelines suggest avoiding gyms, you can still enjoy long walks and outdoor activities. Take the weekend off and don’t work excessively. Sleep well – at least 7-8 hours. which has a series of really excellent meditation and relaxation tools.
- Do not panic. Uncertainty surrounding the pandemic makes all of us anxious and afraid. It is normal to become hypervigilant, especially with our nonstop media. It is normal to be concerned when we feel out of control and when we are hearing about a possible future catastrophe, especially when fed with differing sets of information from multiple sources and countries.
- Be careful with any large decisions you are making that may affect the lives of yourself and your loved ones. Think about your decisions and try to take the long view; and run them by your spouse, partner, or friends. This is not a time to be making sudden big decisions that may be driven unconsciously, in part at least, by fear and anxiety.
- Realize that all of these societal disruptions are actually good for us in health care, and they help your family and friends understand the importance of slowing the disease’s spread. That’s good for health care and good for everyone.
Finally, remember that “this is what we do,” to quote Doug Kirk, MD, chief medical officer of UC Davis Health. We must look after our patients. But we also have to look after ourselves so that we can look after our patients. We should all be proud of our work and our caring. And we should model our personal behavior to our patients and to our families and friends so that they will model it to their community networks. That way, more people will keep well, and we will have more chance of “flattening the curve” and reducing the morbidity and mortality associated with COVID-19.
Peter M. Yellowlees, MBBS, MD, is a professor in the Department of Psychiatry at the University of California, Davis. He is a longtime Medscape contributor.
This article first appeared on Medscape.com.
A message from a Chief Wellness Officer
We are at a time, unfortunately, of significant public uncertainty and fear of “the coronavirus.” Mixed and inaccurate messages from national leaders in the setting of delayed testing availability have heightened fears and impeded a uniformity in responses, medical and preventive.
Despite this, physicians, nurses, and other health professionals across the country, and in many other countries, have been addressing the medical realities of this pandemic in a way that should make every one of us health professionals proud – from the Chinese doctors and nurses to the Italian intensivists and primary care physicians throughout many countries who have treated patients suffering from, or fearful of, a novel disease with uncertain transmission characteristics and unpredictable clinical outcomes.
It is now time for physicians and other health providers in the United States to step up to the plate and model appropriate transmission-reducing behavior for the general public. This will help reduce the overall morbidity and mortality associated with this pandemic and let us return to a more normal lifestyle as soon as possible. Physicians need to be reassuring but realistic, and there are concrete steps that we can take to demonstrate to the general public that there is a way forward.
First the basic facts. The United States does not have enough intensive care beds or ventilators to handle a major pandemic. We will also have insufficient physicians and nurses if many are quarantined. The tragic experience in Italy, where patients are dying from lack of ventilators, intensive care facilities, and staff, must not be repeated here.
Many health systems are canceling or reducing outpatient appointments and increasingly using video and other telehealth technologies, especially for assessing and triaging people who believe that they may have become infected and are relatively asymptomatic. While all of the disruptions may seem unsettling, they are actually good news for those of us in healthcare. Efforts to “flatten the curve” will slow the infection spread and help us better manage patients who become critical.
So, what can physicians do?
- Make sure you are getting good information about the situation. Access reliable information and data that are widely available through the Centers for Disease Control and Prevention, the National Institutes of Health, and the World Health Organization. Listen to professional news organizations, local and national. Pass this information to your patients and community.
- Obviously, when practicing clinically, follow all infection control protocols, which will inevitably change over time. Make it clear to your patients why you are following these protocols and procedures.
- Support and actively promote the public health responses to this pandemic. Systematic reviews of the evidence base have found that isolating ill persons, testing and tracing contacts, quarantining exposed persons, closing schools and workplaces, and avoiding crowding are more effective if implemented immediately, simultaneously (ie, school closures combined with teleworking for parents), and with high community compliance.
- Practice social distancing so that you remain as much in control as you can. This will make you feel psychologically better and safer, as well as reduce the risk for transmission. Take the essential precautionary measures that we are all being asked to take. Wash your hands. Do not shake hands. Clean shared items. Do not go to large public gatherings. Minimize large group travel as much as you can. Use video to see your patients or your own doctor.
- Connect and reconnect with people you trust and love. See your family, your partner, your children, your friends. Speak to them on the phone and nourish those relationships. See how they feel and care for each other. They will be worried about you. Reassure them. Be in the moment with them and use the importance of these relationships to give yourself a chance not to overthink any fears you might have.
- Look after yourself physically. Physical fitness is good for your mental health. While White House guidelines suggest avoiding gyms, you can still enjoy long walks and outdoor activities. Take the weekend off and don’t work excessively. Sleep well – at least 7-8 hours. which has a series of really excellent meditation and relaxation tools.
- Do not panic. Uncertainty surrounding the pandemic makes all of us anxious and afraid. It is normal to become hypervigilant, especially with our nonstop media. It is normal to be concerned when we feel out of control and when we are hearing about a possible future catastrophe, especially when fed with differing sets of information from multiple sources and countries.
- Be careful with any large decisions you are making that may affect the lives of yourself and your loved ones. Think about your decisions and try to take the long view; and run them by your spouse, partner, or friends. This is not a time to be making sudden big decisions that may be driven unconsciously, in part at least, by fear and anxiety.
- Realize that all of these societal disruptions are actually good for us in health care, and they help your family and friends understand the importance of slowing the disease’s spread. That’s good for health care and good for everyone.
Finally, remember that “this is what we do,” to quote Doug Kirk, MD, chief medical officer of UC Davis Health. We must look after our patients. But we also have to look after ourselves so that we can look after our patients. We should all be proud of our work and our caring. And we should model our personal behavior to our patients and to our families and friends so that they will model it to their community networks. That way, more people will keep well, and we will have more chance of “flattening the curve” and reducing the morbidity and mortality associated with COVID-19.
Peter M. Yellowlees, MBBS, MD, is a professor in the Department of Psychiatry at the University of California, Davis. He is a longtime Medscape contributor.
This article first appeared on Medscape.com.
PARAGON-HF: Optimal systolic pressure in HFpEF is 120-129 mm Hg
A target systolic blood pressure (SBP) of 120-129 mm Hg in patients with heart failure with preserved ejection fraction proved to be the sweet spot with the lowest rates of major adverse cardiovascular and renal events in a new analysis from the landmark PARAGON-HF trial.
This finding from the largest-ever randomized, controlled study in heart failure with preserved ejection fraction (HFpEF) strengthens support for current U.S. joint hypertension guidelines, which call for a target SBP less than 130 mm Hg in patients with HFpEF (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803), a recommendation based upon weak evidence until now. That’s because the SPRINT trial, the major impetus for adoption of intensive blood pressure control in the current guidelines, excluded patients with symptomatic HF, Scott D. Solomon, MD, and coinvestigators noted in their new analysis. The study was published in the Journal of the American College of Cardiology and had been planned for presentation during the joint scientific sessions of the American College of Cardiology and the World Heart Federation. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.
The new analysis from PARAGON-HF (Prospective Comparison of ARNI with ARB Global Outcomes in HFpEF) also ruled out the SBP-lowering effect of sacubitril/valsartan (Entresto) as the explanation for the combination drug’s demonstrated beneficial impact on outcomes in the subgroup with an SBP of 120-129 mm Hg. That wasn’t actually a surprise. Indeed, the new study had two hypotheses: one, that the relationship between SBP and cardiovascular and renal outcomes in HFpEF would follow a J-shaped curve, and two, that sacubitril/valsartan’s blood pressure–lowering effect would not account for the drug’s outcome benefits in the subset of HFpEF patients with an SBP in the sweet spot of 120-129 mm Hg. Both hypotheses were borne out, noted Dr. Solomon, professor of medicine at Harvard Medical School and director of noninvasive cardiology at Brigham and Women’s Hospital, both in Boston.
“These data strongly support that additional mechanisms other than blood pressure–lowering account for the benefit. But this is not surprising. The same can be said for most of the therapies that work in heart failure,” he said in an interview.
Take, for example, spironolactone. In TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist), another major trial in which Dr. Solomon played a leadership role, the beneficial effect of spironolactone on clinical outcomes also proved unrelated to the drug’s blood pressure–lowering effect.
Other known effects of sacubitril/valsartan, a novel angiotensin receptor–neprilysin inhibitor, or ARNI, might in theory account for the observed clinical benefits in ARNI-treated patients with an on-treatment SBP of 120-129 mm Hg in PARAGON-HF. These include improved left atrial remodeling, an increase in natriuretic peptides, and improved myocardial relaxation. However, the current lack of understanding of the basic mechanistic processes underlying the varied clinical expressions of HFpEF is a major factor contributing to the lack of any proven-effective therapy for this extremely common and costly disorder, according to Dr. Solomon and coinvestigators.
In contrast to HFpEF, for which to date there is no proven treatment, heart failure with reduced ejection fraction sacubitril/valsartan has a class I recommendation on the strength of its performance in significantly reducing cardiovascular deaths and heart failure hospitalizations in the PARADIGM-HF trial (N Engl J Med. 2014 Sep 11;371:993-1004).
PARAGON-HF included 4,822 patients with symptomatic HFpEF who were randomized to sacubitril/valsartan at 97/103 mg b.i.d. or valsartan at 160 mg b.i.d. As previously reported (N Engl J Med. 2019 Oct 24;381[17]:1609-20), at an average follow-up of 35 months, the primary outcome – a composite of total hospitalizations for heart failure and cardiovascular death – occurred at a rate of 12.8 events per 100 patient-years in the sacubitril/valsartan group and 14.6 per 100 patient-years in the valsartan arm, for a 13% relative risk reduction that narrowly missed statistical significance (P = .059).
However, sacubitril/valsartan showed significant benefit on some prespecified secondary endpoints, including worsening renal function, change in New York Heart Association class, and quality of life. Women, who notably accounted for 52% of study participants, appeared to benefit from sacubitril/valsartan more than men as evidenced by their 27% relative risk reduction in the primary endpoint. Also, in the roughly half of PARAGON-HF participants with a baseline left ventricular ejection fraction of 45%-57%, treatment with sacubitril/valsartan resulted in a statistically significant 22% relative risk reduction in the primary endpoint, compared with valsartan alone.
SBP and cardiovascular outcomes in HFpEF
In the new analysis, Dr. Solomon and coworkers examined outcomes based on baseline and mean achieved SBP quartiles regardless of treatment arm. In an unadjusted analysis, the primary composite endpoint occurred at a rate of 15.2 events/100 patient-years in HFpEF patients with an achieved SBP below 120 mm Hg, 11.4/100 patient-years at 120-129 mm Hg, 12.2/100 patient-years at 130-139 mm Hg, and 15.6/100 patient-years at 140 mm Hg or more. Further, in a multivariate regression analysis extensively adjusted for atrial fibrillation, sex, race, and numerous other potential confounders, the group with an achieved SBP of 120-129 mm Hg continued to fare best. The adjusted risks for the primary endpoint were 11% and 21% higher in patients in the first and third quartiles of achieved SBP, compared with those at 120-129 mm Hg, although neither trend reached statistical significance. But patients in the top quartile, with an achieved SBP of 140 mm Hg or more, had a highly significant 56% increase in risk, compared with patients in the second-lowest SBP quartile.
Change in blood pressure from baseline to week 48 had no impact on quality of life or high-sensitivity troponin T. However, each 10–mm Hg lowering of SBP was associated with a modest 2.1% reduction in log-transformed N-terminal of the prohormone brain natriuretic peptide.
Sacubitril/valsartan reduced SBP by an average of 5.2 mm Hg more than valsartan alone at 4 weeks regardless of baseline SBP. And the combo drug had a significantly greater SBP-lowering effect in women than men, by a margin of 6.3 mm Hg versus 4.0 mm Hg. But a Cox regression analysis showed that in women, as in the study population as a whole, sacubitril/valsartan’s SBP-lowering effects didn’t account for the drug’s impact on outcomes.
In an editorial accompanying publication of the new PARAGON-HF blood pressure analysis (J Am Coll Cardiol. 2020 Mar 16. doi: 10.1016/j.jacc.2020.02.024), Hector O. Ventura, MD, and colleagues at the Ochsner Clinic in New Orleans observed that the study results “lend some credence to the prognostic relationship of blood pressure in HFpEF, but whether they should serve as a therapeutic target or are merely a prognostic surrogate determined by other pathogenic factors, such as vascular ventricular uncoupling or aortic stiffness on one hand when blood pressure is greater than 140 mm Hg, or a reduced cardiac performance indicated by reduced blood pressure to less than 120 mm Hg, remains uncertain.”
“What is certain, however, is that the relationship and contributions of hypertension in manifest HFpEF are complex, multifactorial and likely go well beyond a simplistic framework of hemodynamic influences,” they added.
Dr. Solomon has received research grants from and serves as a consultant to Novartis, which funded PARAGON-HF, and has similar financial relationships with more than a dozen other pharmaceutical companies. Dr. Ventura reported having no relevant financial interests.
SOURCE: Solomon SD et al. J Am Coll Cardiol. 2020 Mar 16. doi: 10.1016/j.jacc.2020.02.009.
A target systolic blood pressure (SBP) of 120-129 mm Hg in patients with heart failure with preserved ejection fraction proved to be the sweet spot with the lowest rates of major adverse cardiovascular and renal events in a new analysis from the landmark PARAGON-HF trial.
This finding from the largest-ever randomized, controlled study in heart failure with preserved ejection fraction (HFpEF) strengthens support for current U.S. joint hypertension guidelines, which call for a target SBP less than 130 mm Hg in patients with HFpEF (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803), a recommendation based upon weak evidence until now. That’s because the SPRINT trial, the major impetus for adoption of intensive blood pressure control in the current guidelines, excluded patients with symptomatic HF, Scott D. Solomon, MD, and coinvestigators noted in their new analysis. The study was published in the Journal of the American College of Cardiology and had been planned for presentation during the joint scientific sessions of the American College of Cardiology and the World Heart Federation. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.
The new analysis from PARAGON-HF (Prospective Comparison of ARNI with ARB Global Outcomes in HFpEF) also ruled out the SBP-lowering effect of sacubitril/valsartan (Entresto) as the explanation for the combination drug’s demonstrated beneficial impact on outcomes in the subgroup with an SBP of 120-129 mm Hg. That wasn’t actually a surprise. Indeed, the new study had two hypotheses: one, that the relationship between SBP and cardiovascular and renal outcomes in HFpEF would follow a J-shaped curve, and two, that sacubitril/valsartan’s blood pressure–lowering effect would not account for the drug’s outcome benefits in the subset of HFpEF patients with an SBP in the sweet spot of 120-129 mm Hg. Both hypotheses were borne out, noted Dr. Solomon, professor of medicine at Harvard Medical School and director of noninvasive cardiology at Brigham and Women’s Hospital, both in Boston.
“These data strongly support that additional mechanisms other than blood pressure–lowering account for the benefit. But this is not surprising. The same can be said for most of the therapies that work in heart failure,” he said in an interview.
Take, for example, spironolactone. In TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist), another major trial in which Dr. Solomon played a leadership role, the beneficial effect of spironolactone on clinical outcomes also proved unrelated to the drug’s blood pressure–lowering effect.
Other known effects of sacubitril/valsartan, a novel angiotensin receptor–neprilysin inhibitor, or ARNI, might in theory account for the observed clinical benefits in ARNI-treated patients with an on-treatment SBP of 120-129 mm Hg in PARAGON-HF. These include improved left atrial remodeling, an increase in natriuretic peptides, and improved myocardial relaxation. However, the current lack of understanding of the basic mechanistic processes underlying the varied clinical expressions of HFpEF is a major factor contributing to the lack of any proven-effective therapy for this extremely common and costly disorder, according to Dr. Solomon and coinvestigators.
In contrast to HFpEF, for which to date there is no proven treatment, heart failure with reduced ejection fraction sacubitril/valsartan has a class I recommendation on the strength of its performance in significantly reducing cardiovascular deaths and heart failure hospitalizations in the PARADIGM-HF trial (N Engl J Med. 2014 Sep 11;371:993-1004).
PARAGON-HF included 4,822 patients with symptomatic HFpEF who were randomized to sacubitril/valsartan at 97/103 mg b.i.d. or valsartan at 160 mg b.i.d. As previously reported (N Engl J Med. 2019 Oct 24;381[17]:1609-20), at an average follow-up of 35 months, the primary outcome – a composite of total hospitalizations for heart failure and cardiovascular death – occurred at a rate of 12.8 events per 100 patient-years in the sacubitril/valsartan group and 14.6 per 100 patient-years in the valsartan arm, for a 13% relative risk reduction that narrowly missed statistical significance (P = .059).
However, sacubitril/valsartan showed significant benefit on some prespecified secondary endpoints, including worsening renal function, change in New York Heart Association class, and quality of life. Women, who notably accounted for 52% of study participants, appeared to benefit from sacubitril/valsartan more than men as evidenced by their 27% relative risk reduction in the primary endpoint. Also, in the roughly half of PARAGON-HF participants with a baseline left ventricular ejection fraction of 45%-57%, treatment with sacubitril/valsartan resulted in a statistically significant 22% relative risk reduction in the primary endpoint, compared with valsartan alone.
SBP and cardiovascular outcomes in HFpEF
In the new analysis, Dr. Solomon and coworkers examined outcomes based on baseline and mean achieved SBP quartiles regardless of treatment arm. In an unadjusted analysis, the primary composite endpoint occurred at a rate of 15.2 events/100 patient-years in HFpEF patients with an achieved SBP below 120 mm Hg, 11.4/100 patient-years at 120-129 mm Hg, 12.2/100 patient-years at 130-139 mm Hg, and 15.6/100 patient-years at 140 mm Hg or more. Further, in a multivariate regression analysis extensively adjusted for atrial fibrillation, sex, race, and numerous other potential confounders, the group with an achieved SBP of 120-129 mm Hg continued to fare best. The adjusted risks for the primary endpoint were 11% and 21% higher in patients in the first and third quartiles of achieved SBP, compared with those at 120-129 mm Hg, although neither trend reached statistical significance. But patients in the top quartile, with an achieved SBP of 140 mm Hg or more, had a highly significant 56% increase in risk, compared with patients in the second-lowest SBP quartile.
Change in blood pressure from baseline to week 48 had no impact on quality of life or high-sensitivity troponin T. However, each 10–mm Hg lowering of SBP was associated with a modest 2.1% reduction in log-transformed N-terminal of the prohormone brain natriuretic peptide.
Sacubitril/valsartan reduced SBP by an average of 5.2 mm Hg more than valsartan alone at 4 weeks regardless of baseline SBP. And the combo drug had a significantly greater SBP-lowering effect in women than men, by a margin of 6.3 mm Hg versus 4.0 mm Hg. But a Cox regression analysis showed that in women, as in the study population as a whole, sacubitril/valsartan’s SBP-lowering effects didn’t account for the drug’s impact on outcomes.
In an editorial accompanying publication of the new PARAGON-HF blood pressure analysis (J Am Coll Cardiol. 2020 Mar 16. doi: 10.1016/j.jacc.2020.02.024), Hector O. Ventura, MD, and colleagues at the Ochsner Clinic in New Orleans observed that the study results “lend some credence to the prognostic relationship of blood pressure in HFpEF, but whether they should serve as a therapeutic target or are merely a prognostic surrogate determined by other pathogenic factors, such as vascular ventricular uncoupling or aortic stiffness on one hand when blood pressure is greater than 140 mm Hg, or a reduced cardiac performance indicated by reduced blood pressure to less than 120 mm Hg, remains uncertain.”
“What is certain, however, is that the relationship and contributions of hypertension in manifest HFpEF are complex, multifactorial and likely go well beyond a simplistic framework of hemodynamic influences,” they added.
Dr. Solomon has received research grants from and serves as a consultant to Novartis, which funded PARAGON-HF, and has similar financial relationships with more than a dozen other pharmaceutical companies. Dr. Ventura reported having no relevant financial interests.
SOURCE: Solomon SD et al. J Am Coll Cardiol. 2020 Mar 16. doi: 10.1016/j.jacc.2020.02.009.
A target systolic blood pressure (SBP) of 120-129 mm Hg in patients with heart failure with preserved ejection fraction proved to be the sweet spot with the lowest rates of major adverse cardiovascular and renal events in a new analysis from the landmark PARAGON-HF trial.
This finding from the largest-ever randomized, controlled study in heart failure with preserved ejection fraction (HFpEF) strengthens support for current U.S. joint hypertension guidelines, which call for a target SBP less than 130 mm Hg in patients with HFpEF (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803), a recommendation based upon weak evidence until now. That’s because the SPRINT trial, the major impetus for adoption of intensive blood pressure control in the current guidelines, excluded patients with symptomatic HF, Scott D. Solomon, MD, and coinvestigators noted in their new analysis. The study was published in the Journal of the American College of Cardiology and had been planned for presentation during the joint scientific sessions of the American College of Cardiology and the World Heart Federation. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.
The new analysis from PARAGON-HF (Prospective Comparison of ARNI with ARB Global Outcomes in HFpEF) also ruled out the SBP-lowering effect of sacubitril/valsartan (Entresto) as the explanation for the combination drug’s demonstrated beneficial impact on outcomes in the subgroup with an SBP of 120-129 mm Hg. That wasn’t actually a surprise. Indeed, the new study had two hypotheses: one, that the relationship between SBP and cardiovascular and renal outcomes in HFpEF would follow a J-shaped curve, and two, that sacubitril/valsartan’s blood pressure–lowering effect would not account for the drug’s outcome benefits in the subset of HFpEF patients with an SBP in the sweet spot of 120-129 mm Hg. Both hypotheses were borne out, noted Dr. Solomon, professor of medicine at Harvard Medical School and director of noninvasive cardiology at Brigham and Women’s Hospital, both in Boston.
“These data strongly support that additional mechanisms other than blood pressure–lowering account for the benefit. But this is not surprising. The same can be said for most of the therapies that work in heart failure,” he said in an interview.
Take, for example, spironolactone. In TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist), another major trial in which Dr. Solomon played a leadership role, the beneficial effect of spironolactone on clinical outcomes also proved unrelated to the drug’s blood pressure–lowering effect.
Other known effects of sacubitril/valsartan, a novel angiotensin receptor–neprilysin inhibitor, or ARNI, might in theory account for the observed clinical benefits in ARNI-treated patients with an on-treatment SBP of 120-129 mm Hg in PARAGON-HF. These include improved left atrial remodeling, an increase in natriuretic peptides, and improved myocardial relaxation. However, the current lack of understanding of the basic mechanistic processes underlying the varied clinical expressions of HFpEF is a major factor contributing to the lack of any proven-effective therapy for this extremely common and costly disorder, according to Dr. Solomon and coinvestigators.
In contrast to HFpEF, for which to date there is no proven treatment, heart failure with reduced ejection fraction sacubitril/valsartan has a class I recommendation on the strength of its performance in significantly reducing cardiovascular deaths and heart failure hospitalizations in the PARADIGM-HF trial (N Engl J Med. 2014 Sep 11;371:993-1004).
PARAGON-HF included 4,822 patients with symptomatic HFpEF who were randomized to sacubitril/valsartan at 97/103 mg b.i.d. or valsartan at 160 mg b.i.d. As previously reported (N Engl J Med. 2019 Oct 24;381[17]:1609-20), at an average follow-up of 35 months, the primary outcome – a composite of total hospitalizations for heart failure and cardiovascular death – occurred at a rate of 12.8 events per 100 patient-years in the sacubitril/valsartan group and 14.6 per 100 patient-years in the valsartan arm, for a 13% relative risk reduction that narrowly missed statistical significance (P = .059).
However, sacubitril/valsartan showed significant benefit on some prespecified secondary endpoints, including worsening renal function, change in New York Heart Association class, and quality of life. Women, who notably accounted for 52% of study participants, appeared to benefit from sacubitril/valsartan more than men as evidenced by their 27% relative risk reduction in the primary endpoint. Also, in the roughly half of PARAGON-HF participants with a baseline left ventricular ejection fraction of 45%-57%, treatment with sacubitril/valsartan resulted in a statistically significant 22% relative risk reduction in the primary endpoint, compared with valsartan alone.
SBP and cardiovascular outcomes in HFpEF
In the new analysis, Dr. Solomon and coworkers examined outcomes based on baseline and mean achieved SBP quartiles regardless of treatment arm. In an unadjusted analysis, the primary composite endpoint occurred at a rate of 15.2 events/100 patient-years in HFpEF patients with an achieved SBP below 120 mm Hg, 11.4/100 patient-years at 120-129 mm Hg, 12.2/100 patient-years at 130-139 mm Hg, and 15.6/100 patient-years at 140 mm Hg or more. Further, in a multivariate regression analysis extensively adjusted for atrial fibrillation, sex, race, and numerous other potential confounders, the group with an achieved SBP of 120-129 mm Hg continued to fare best. The adjusted risks for the primary endpoint were 11% and 21% higher in patients in the first and third quartiles of achieved SBP, compared with those at 120-129 mm Hg, although neither trend reached statistical significance. But patients in the top quartile, with an achieved SBP of 140 mm Hg or more, had a highly significant 56% increase in risk, compared with patients in the second-lowest SBP quartile.
Change in blood pressure from baseline to week 48 had no impact on quality of life or high-sensitivity troponin T. However, each 10–mm Hg lowering of SBP was associated with a modest 2.1% reduction in log-transformed N-terminal of the prohormone brain natriuretic peptide.
Sacubitril/valsartan reduced SBP by an average of 5.2 mm Hg more than valsartan alone at 4 weeks regardless of baseline SBP. And the combo drug had a significantly greater SBP-lowering effect in women than men, by a margin of 6.3 mm Hg versus 4.0 mm Hg. But a Cox regression analysis showed that in women, as in the study population as a whole, sacubitril/valsartan’s SBP-lowering effects didn’t account for the drug’s impact on outcomes.
In an editorial accompanying publication of the new PARAGON-HF blood pressure analysis (J Am Coll Cardiol. 2020 Mar 16. doi: 10.1016/j.jacc.2020.02.024), Hector O. Ventura, MD, and colleagues at the Ochsner Clinic in New Orleans observed that the study results “lend some credence to the prognostic relationship of blood pressure in HFpEF, but whether they should serve as a therapeutic target or are merely a prognostic surrogate determined by other pathogenic factors, such as vascular ventricular uncoupling or aortic stiffness on one hand when blood pressure is greater than 140 mm Hg, or a reduced cardiac performance indicated by reduced blood pressure to less than 120 mm Hg, remains uncertain.”
“What is certain, however, is that the relationship and contributions of hypertension in manifest HFpEF are complex, multifactorial and likely go well beyond a simplistic framework of hemodynamic influences,” they added.
Dr. Solomon has received research grants from and serves as a consultant to Novartis, which funded PARAGON-HF, and has similar financial relationships with more than a dozen other pharmaceutical companies. Dr. Ventura reported having no relevant financial interests.
SOURCE: Solomon SD et al. J Am Coll Cardiol. 2020 Mar 16. doi: 10.1016/j.jacc.2020.02.009.
FROM ACC 2020